A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects
Phase: PHASE3
Conditions: Schizophrenia, Autism, Bipolar Depression
Sponsor: Sumitomo Pharma America, Inc.

Title page
 
LURASIDONE 
D1050302 
A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, 
MULTICENTER, EXTENSION STUDY TO EVALUATE 
THE LONG-TERM SAFETY AND EFFECTIVENESS OF 
LURASIDONE IN PEDIATRIC SUBJECTS  
IND Nos. 61,292 and 103,427 
EudraCT No. 2013-001694-24 
Version 4.0 
30 June 2017 
Incorporates Amendment 3 and Non-substantial Protocol Amendment 1.00 
SUNOVION PHARMACEUTICALS INC. 
One Bridge Plaza Suite 510 
Fort Lee, NJ 07024 
USA 
(201) 592-2050 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
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RESTRICTED DISTRIBUTION OF PROTOCOLS 
This document contains information confidential and/or of proprietary interest to Sumitomo 
Dainippon Pharma Co. Ltd. and/or Sunovion Pharmaceuticals Inc. (including their 
The information cannot be disclosed to any third party or 
predecessors, subsidiaries or affiliates). 
used for any purpose other than the purpose for which it is being submitted without the prior 
written consent of the appropriate Sumitomo Dainippon Pharma company. 
This information is being provided to you for the purpose of conducting a clinical study for 
. (hereafter referred to as Sunovion, or Sponsor). You may 
Sunovion Pharmaceuticals Inc
disclose the contents of this protocol to the study personnel under your supervision and to your 
Institutional Review Board or Independent Ethics Committee for the above purpose. You may 
not disclose the contents of this protocol to any other parties, unless such disclosure is required 
by government regulations or laws, without the prior written permission of Sunovion. 
Any data gathered during the conduct of this protocol and supplemental information (eg, a 
 
protocol amendment) that may be added to this document is also proprietary to Sunovion, and 
should be handled consistently with that stated above. 
 

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EMERGENCY CONTACTS 
Table 1: 
Emergency Contact Information 
Role in Study 
Name 
Contact Information 
Clinical Study Leader 
 
Head of Global Clinical Research, 
Psychiatry 
Sunovion Pharmaceuticals Inc. 
Medical Monitor 
 
Executive Director, Medical and 
Scientific Services 
Quintiles 
SAE Reporting 
SunovionSafety@druginfo.com   
SAE Reporting in EU 
and Africa 
 
Principal Drug Safety Scientist 
Sunovion Pharmaceuticals Europe, 
Ltd. 
 

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1.
SYNOPSIS
Name of Sponsor/Company: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone (lurasidone HCl) 
Title of Study: A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the 
Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects  
Study Centers: Multicenter study in the United States and Worldwide 
Phase of Development: 3 
Study Objectives:  
Primary: To evaluate the long-term safety, tolerability, and effectiveness of lurasidone (20, 40, 60 or 
80 mg/day, flexibly dosed) in pediatric subjects who have completed a prior lurasidone study. 
Secondary: 
For all subjects, the following will be assessed: 
•
Proportions of subjects with adverse events (AEs), discontinuations due to AEs, and serious
AEs (SAEs). 
For subjects continued from Study D1050301, the following will be assessed: 
•
Change in Positive and Negative Syndrome Scale (PANSS) total, positive, negative, general
psychopathology, and excitability subscale scores; 
•
Change in the Clinical Global Impression – Severity (CGI-S);
•
Change in the Clinician-rated Children’s Global Assessment Scale (CGAS);
•
Change in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire
(PQ-LES-Q).
For subjects continued from Study D1050325, the following will be assessed: 
•
Change in Aberrant Behavior Checklist (ABC) irritability subscale, and the following subscale
scores (hyperactivity, stereotypy, inappropriate speech, and lethargy/social withdrawal); 
•
Change in the Clinical Global Impression – Severity (CGI-S);
•
Change in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for
pervasive developmental disorders (PDDs);
•
Change in the Caregiver Strain Questionnaire (CGSQ).
For subjects continued from Study D1050326, the following will be assessed: 
•
Change in the Children's Depression Rating Scale, Revised (CDRS-R);
•
Change in the Clinical Global Impression Bipolar Version – Severity (CGI-BP-S);
•
Change in the Clinician-rated Children’s Global Assessment Scale (CGAS);
•
Change in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire
(PQ-LES-Q);
•
Change in anxiety symptoms as measured by the Pediatric Anxiety Rating Scale (PARS);
•
Change in attention-deficit/hyperactivity symptoms as measured by the Attention-Deficit/
Hyperactivity Disorder Rating Scale (ADHD-RS) total score.
Study Design:  
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term 
safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric 

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Name of Sponsor/Company: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone (lurasidone HCl) 
subjects who have completed the 6-week treatment period in the preceding studies, D1050301, 
D1050325, or D1050326.   
Subjects who complete participation in the preceding studies, D1050301, D1050325, or D1050326 will 
be eligible for enrollment in this study. Informed consent/assent will be obtained from all subjects 
(where developmentally appropriate) before any study procedures are performed. Subjects who meet 
entry criteria will transition to this study directly from Study D1050301, D1050325, or D1050326. All 
subjects will be treated with flexibly dosed lurasidone during the trial. 
A reliable informant (eg, parent, legal guardian, or caregiver) of the subject must accompany the 
subject at each visit. For subjects entering from Study D1050325, the reliable caregiver will also 
oversee the administration of the study drug throughout the study. 
All eligible subjects will be treated with lurasidone 40 mg/day for Days 1-7. Beginning with Day 8, 
dose adjustments (20, 40, 60 or 80 mg/day) will be permitted, based on investigator judgment, to 
optimize tolerability and effectiveness.  
Dose adjustment of study drug should occur at the regularly scheduled visits and in increments or 
decrements of 1 dose level. However, dose reductions for tolerability or safety purposes may occur 
beginning on Day 2, based on investigator judgment. These dose reductions may be between study 
visits and at more than 1 dose level at a time (maximum of 2 dose levels at a time). If dose reductions 
are required between regular study visits, the subject must return to the study site for an unscheduled 
visit to receive new medication kits and return all used/unused medication kits at the time of dose 
adjustment. 
Safety and effectiveness assessments will be conducted at scheduled visits during the study. 
A follow-up visit will occur 1 week post last dose of study drug. 
A Data and Safety Monitoring Board (DSMB) will review safety and clinical outcome data including 
data on adverse events (AEs) and serious adverse events (SAEs) at regular intervals until the 
D1050301, D1050325, and D1050326 studies are complete and as long as necessary for the D1050302 
study, as determined by the Sponsor. The DSMB will be independent of the Sponsor, contract research 
organization (CRO), and the investigators and will be empowered to recommend stopping the study 
due to safety concerns, but not for efficacy or futility. The membership of the DSMB and its mandate is 
denoted in the DSMB charter. 
Number of Subjects (planned): The estimated number of subjects eligible for enrollment is 
approximately 702 subjects. 
Diagnosis and Main Criteria for Inclusion: 
Subject has completed Study D1050301 (Visit 9), Study D1050325 (Visit 9), or Study D1050326 
(Visit 8); is judged to be appropriate for long-term treatment with lurasidone; has provided informed 
assent/consent (where developmentally appropriate); and has met all other entry criteria. 
Investigational Product, Dosage and Mode of Administration: Subjects will receive lurasidone 
(lurasidone HCl) administered orally, 20, 40, 60 or 80 mg (flexibly dosed), once daily in the evening 
with food (at least 350 calories) or within 30 minutes after eating. 
Duration of Treatment: 24 months (104 weeks) 
Reference Therapy, Dosage and Mode of Administration: Not applicable 
Criteria for Evaluation: 
Safety Assessments:  

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Name of Sponsor/Company: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone (lurasidone HCl) 
All Subjects: 
•
Treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and serious
AEs (SAEs); 
•
Laboratory tests, vital signs, body weight and body mass index (BMI), waist circumference,
physical examination, height (as measured by stadiometer), electrocardiogram (ECG), 
hormonal parameters; 
•
Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes
Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS); 
•
Tanner staging, and menstrual cyclicity (female subjects).
For subjects continued from Study D1050301 and D1050326: 
•
Columbia Suicide Severity Rating Scale (C-SSRS);
•
CogState Computerized Cognitive Test Battery;
•
Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU).
For subjects continued from Study D1050326: 
•
Young Mania Rating Scale (YMRS) score.
Effectiveness Assessments: 
For subjects continued from Study D1050301: 
•
Positive and Negative Syndrome Scale (PANSS);
•
Clinical Global Impression-Severity (CGI-S) scale;
•
Clinician-rated Children’s Global Assessment Scale (CGAS);
•
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q).
For subjects continued from Study D1050325: 
•
Aberrant Behavior Checklist (ABC);
•
Clinical Global Impression-Severity (CGI-S) scale.
•
Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for pervasive
developmental disorders (PDDs);
•
Caregiver Strain Questionnaire (CGSQ).
For subjects continued from Study D1050326: 
•
Children's Depression Rating Scale, Revised (CDRS-R);
•
Clinical Global Impression Bipolar Version -Severity (CGI-BP-S) scale;
•
Clinician-rated Children’s Global Assessment Scale (CGAS);
•
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q);
•
Pediatric Anxiety Rating Scale (PARS);
•
Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS).
Statistical Methods: 
The safety population will include all subjects who receive at least one dose of study medication. A 
total of three analysis groups will be formed based on a subject’s previous participation status in 
double-blind studies D1050301, D1050325, or D1050326. Safety and efficacy analyses will be 

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Name of Sponsor/Company: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone (lurasidone HCl) 
presented by the above analysis groups, respectively. In efficacy and safety analyses, the pre-treatment 
baseline from studies D1050301, D1050325, or D1050326 will be referred to as the double-blind study 
baseline or "DB baseline," and the last assessment prior to the first dose in the open-label study 
D1050302 will be referred to as the open label study baseline or "OL baseline." No statistical 
comparisons will be conducted for treatment groups. 
Safety Analyses: 
For all subjects: 
The incidence of AEs, SAEs, and discontinuations due to AEs. AEs (or SAEs) will be summarized by 
presenting the number and percentage of subjects having each individual AE (or SAE) by analysis 
group. Discontinuations due to AEs and SAEs will be summarized by presenting number and 
percentage of subjects terminated prematurely due to AEs or SAEs by analysis group. 
Descriptive statistics will also be provided for the following safety variables and the corresponding 
changes from baseline: body weight, height, body mass index (BMI), waist circumference, vital signs, 
electrocardiogram (ECG) parameters, movement disorders as assessed by Abnormal Involuntary 
Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale 
(SAS), Tanner staging, and menstrual cyclicity (female subjects), physical examination results, and 
standard laboratory tests covering hematology, chemistry, hormonal parameters, and urinalysis. 
For subjects continued from Study D1050301 and D1050326: 
Descriptive statistics will also be provided for the CogState Computerized Cognitive Test Battery, and 
Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) by visit for each analysis group. 
For C-SSRS data, number and percentage of subjects with suicidal ideations and behaviors will be 
summarized. 
For subjects continued from Study D1050326: 
Descriptive statistics will be presented for YMRS result by analysis group and study visit. 
For above safety analyses, continuous variables will be summarized using descriptive statistics of 
number of subjects, mean, standard deviation, median, minimum and maximum values. Categorical 
variables will be reported as frequencies and percentages. 
Effectiveness Analyses 
This open-label study includes subjects coming from three different studies (D1050301, D1050325, 
and D1050326). Efficacy variables to be summarized for this study will include: 
For subjects continued from Study D1050301: 
Descriptive statistics of observed value and change from DB baseline and OL baseline in PANSS total 
score and positive, negative, general psychopathology, and excitability subscale scores, CGI-S, CGAS, 
and PQ-LES-Q scores will be provided by visit and by analysis group.  
For subjects continued from Study D1050325: 
Descriptive statistics of observed value and change from DB baseline and OL baseline in ABC 
subscale scores (irritability, hyperactivity, stereotypy, inappropriate speech, and lethargy/social 
withdrawal), CGI-S, CY-BOCS, and CGSQ scores will be provided by visit and by analysis group. 
For subjects continued from Study D1050326: 
Descriptive statistics of observed value and change from DB baseline and OL baseline in CDRS-R, 
CGI-BP-S, CGAS, PQ-LES-Q, PARS, and ADHD-RS scores will be provided by visit and by analysis 
group. 
For above effectiveness analyses, descriptive statistics, including number of subjects, mean, standard 

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Name of Sponsor/Company: Sunovion Pharmaceuticals Inc. 
Name of Investigational Product: Lurasidone (lurasidone HCl) 
deviation, median, minimum, maximum, and a 95% confidence interval, will be provided. Since this is 
an uncontrolled open-label extension of studies D1050301, D1050325, or D1050326, no inferential 
statistics on effectiveness will be presented. 
Sample Size:  
Subjects who complete the respective double-blind studies D1050301, D1050325 or D1050326, sign 
the consent, and meet all entry criteria will be included in this study. Studies D1050301, D1050325, 
and D1050326 have finished, with a total of 271 subjects from D1050301, 125 subjects from 
D1050325, and 306 subjects from D1050326 enrolling into D1050302. Based on an estimated attrition 
rate of approximately 30% of subjects over six months, it is expected that at least 100 subjects will be 
exposed to lurasidone for a minimum of 6 months for subjects continued from Studies D1050301 and 
D1050325 in Study D1050302. 
Data Analyses of Interim Data for FDA Filing 
After studies D1050301 and D1050325 are completed, when at least 100 subjects previously from 
these two studies complete the Week 28 visit (ie, exposed to study drug for at least 6 months), data 
analyses based on these interim data will be done to prepare a safety/effectiveness report in support of 
the initial health authority filing for US regulatory submission for the lurasidone pediatric program. A 
subsequent final analysis of study D1050302 will be performed after every subject previously enrolled 
from study D1050301, D1050325, and D1050326 complete the study. 
 

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2. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES  
TABLE OF CONTENTS 
1. 
SYNOPSIS ...................................................................................................................4 
2. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES .................9 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS .............................15 
4. 
INTRODUCTION ......................................................................................................18 
4.1. 
Previous Human Experience in Pediatric Subjects .....................................................18 
4.2. 
Study Rationale ...........................................................................................................18 
4.3. 
Dose Justification ........................................................................................................18 
5. 
STUDY OBJECTIVES ..............................................................................................19 
5.1. 
Primary Objective .......................................................................................................19 
5.2. 
Secondary Objectives .................................................................................................19 
6. 
STUDY ENDPOINTS ................................................................................................20 
6.1. 
Safety Assessments .....................................................................................................20 
6.2. 
Effectiveness Assessments .........................................................................................20 
7. 
INVESTIGATIONAL PLAN .....................................................................................22 
7.1. 
Overall Study Design ..................................................................................................22 
7.2. 
Study Termination Criteria .........................................................................................23 
8. 
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................33 
8.1. 
Subject Inclusion Criteria ...........................................................................................33 
8.2. 
Subject Exclusion Criteria ..........................................................................................34 
9. 
TREATMENT OF SUBJECTS ..................................................................................35 
9.1. 
Concomitant Medications ...........................................................................................35 
9.1.1. 
Concomitant Non-psychotropic Medications .............................................................35 
9.1.2. 
Concomitant Psychotropic Medications .....................................................................35 
9.2. 
Treatment Compliance ................................................................................................36 
9.3. 
Hospitalization ............................................................................................................36 
10. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................38 
10.1. 
Description of Study Drug ..........................................................................................38 
10.2. 
Study Drug Packaging and Labeling ..........................................................................38 
10.2.1. 
Blister Cards ...............................................................................................................38 

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10.3. 
Study Drug Storage .....................................................................................................39 
10.4. 
Study Drug Dispensation and Handling .....................................................................39 
10.5. 
Interactive Voice Response/Web Response System (IXRS) ......................................40 
10.6. 
Administration ............................................................................................................40 
10.7. 
Study Drug Accountability .........................................................................................40 
11. 
TREATMENT PLAN .................................................................................................41 
11.1. 
Study Assessments ......................................................................................................41 
11.1.1. 
Effectiveness ...............................................................................................................41 
11.1.2. 
Safety ..........................................................................................................................43 
11.2. 
Standardization of Data Capture .................................................................................46 
11.3. 
Electronic Data Capture (EDC) ..................................................................................46 
11.4. 
Study Visits and Assessments ....................................................................................46 
11.4.1. 
Visit 1E (Day 1) ..........................................................................................................46 
11.4.2. 
Visit 2E (Week 2) .......................................................................................................47 
11.4.3. 
Visit 3E (Week 4) .......................................................................................................47 
11.4.4. 
Visit 4E (Week 6) .......................................................................................................48 
11.4.5. 
Visit 5E (Week 8) .......................................................................................................49 
11.4.6. 
Visit 6E (Week 12) .....................................................................................................50 
11.4.7. 
Visit 7E (Week 16) .....................................................................................................51 
11.4.8. 
Visit 8E (Week 20) .....................................................................................................52 
11.4.9. 
Visit 9E (Week 24) .....................................................................................................53 
11.4.10. 
Visit 10E (Week 28) ...................................................................................................54 
11.4.11. 
Visit 11E (Week 32) ...................................................................................................55 
11.4.12. 
Visit 12E (Week 36) ...................................................................................................56 
11.4.13. 
Visit 13E (Week 40) ...................................................................................................57 
11.4.14. 
Visit 14E (Week 44) ...................................................................................................58 
11.4.15. 
Visit 15E (Week 48) ...................................................................................................59 
11.4.16. 
Visit 16E (Week 52) ...................................................................................................59 
11.4.17. 
Visit 17E (Week 56) ...................................................................................................61 
11.4.18. 
Visit 18E (Week 60) ...................................................................................................62 
11.4.19. 
Visit 19E (Week 64) ...................................................................................................63 
11.4.20. 
Visit 20E (Week 68) ...................................................................................................64 
11.4.21. 
Visit 21E (Week 72) ...................................................................................................65 

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11.4.22. 
Visit 22E (Week 76) ...................................................................................................65 
11.4.23. 
Visit 23E (Week 80) ...................................................................................................67 
11.4.24. 
Visit 24E (Week 84) ...................................................................................................68 
11.4.25. 
Visit 25E (Week 88) ...................................................................................................68 
11.4.26. 
Visit 26E (Week 92) ...................................................................................................70 
11.4.27. 
Visit 27E (Week 96) ...................................................................................................70 
11.4.28. 
Visit 28E (Week 100) .................................................................................................71 
11.4.29. 
Visit 29E EOS/ET (Week 104) ...................................................................................72 
11.4.30. 
Visit 30E (Week 105) .................................................................................................73 
12. 
DISCONTINUATION AND REPLACEMENT OF SUBJECTS/ 
CLINICAL ASSESSMENTS AFTER STUDY MEDICATION 
DISCONTINUATION ...............................................................................................75 
12.1. 
Study Participation Termination Criteria ....................................................................75 
12.2. 
Follow-up Procedures Upon Discontinuation/Withdrawal ........................................75 
13. 
ADVERSE EXPERIENCE REPORTING .................................................................76 
13.1. 
Adverse Events ...........................................................................................................76 
13.2. 
Objective Findings ......................................................................................................76 
13.3. 
Immediately Reportable Events ..................................................................................77 
13.3.1. 
Bone Fractures ............................................................................................................78 
13.4. 
Preplanned Hospitalizations or Procedures ................................................................78 
13.5. 
Data and Safety Monitoring Board .............................................................................78 
14. 
STATISTICS ..............................................................................................................79 
14.1. 
Randomization and Blinding ......................................................................................79 
14.2. 
Unblinding Procedures ...............................................................................................79 
14.3. 
Hypotheses ..................................................................................................................79 
14.4. 
Variables and Timepoints ...........................................................................................79 
14.4.1. 
Primary Safety Variables ............................................................................................79 
14.4.2. 
Other Safety Variables ................................................................................................79 
14.5. 
Sample Size Considerations .......................................................................................79 
14.6. 
Data Analyses of Interim Data for FDA Filing ..........................................................79 
14.7. 
Data Analyses .............................................................................................................80 
14.7.1. 
Analysis Population ....................................................................................................80 
14.7.2. 
Definitions of Assessments .........................................................................................80 

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14.7.3. 
Analysis Group ...........................................................................................................81 
14.7.4. 
Statistical Methods ......................................................................................................81 
14.7.4.1. 
Efficacy Evaluation ....................................................................................................81 
14.7.4.2. 
Safety Evaluation ........................................................................................................82 
15. 
COMPUTERIZED SYSTEMS USED FOR SOURCE DATA .................................84 
16. 
ETHICAL AND REGULATORY OBLIGATIONS ..................................................86 
16.1. 
Study Conduct ............................................................................................................86 
16.2. 
Institutional Review Board or Independent Ethics Committee ..................................86 
16.3. 
Informed Consent .......................................................................................................87 
16.4. 
Subject Privacy ...........................................................................................................88 
16.5. 
Protocol Amendments and Emergency Deviations ....................................................88 
16.6. 
Monitoring and Auditing of the Study ........................................................................88 
16.7. 
Study Documentation .................................................................................................89 
16.8. 
Laboratory Certification and Normal Values .............................................................89 
16.9. 
Records Retention .......................................................................................................89 
16.10. 
Inspection of Records .................................................................................................90 
16.11. 
Financial Disclosure ...................................................................................................90 
17. 
STUDY ACKNOWLEDGMENT ..............................................................................91 
18. 
REFERENCES ...........................................................................................................92 
APPENDIX A. CLINICAL LABORATORY TESTS ...............................................................93 
APPENDIX B. POTENT INHIBITORS AND INDUCERS OF THE 
CYP3A4 ENZYME SYSTEM ...................................................................................95 
APPENDIX C. DEFINITIONS FOR REPORTING ADVERSE EVENTS ..............................96 
 

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LIST OF TABLES 
Table 1: 
Emergency Contact Information ...................................................................................3 
Table 2: 
Abbreviations and Specialist Terms ...........................................................................15 
Table 3: 
Schedule of Assessments Enrollment to Week 40 .....................................................24 
Table 4: 
Schedule of Assessments - Week 44 to 92 .................................................................27 
Table 5: 
Schedule of Assessments - Week 96 to 105 ...............................................................30 
Table 6: 
Investigational Product ...............................................................................................38 
Table 7: 
Blister Card and Carton Label Example .....................................................................39 
Table 8: 
Computerized Systems Used for Source Data ............................................................84 
Table 9: 
Total Blood Drawn For Laboratory Tests ..................................................................94 
 

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LIST OF FIGURES 
Figure 1: 
Study Schematic .........................................................................................................23 
 
  

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3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Table 2: 
Abbreviations and Specialist Terms  
For the purposes of standardization, the following definitions will be used:  
Abbreviation  
Term 
5-HT 
5-hydroxytryptamine 
ABC 
Aberrant Behavior Checklist 
ADHD-RS 
Attention-Deficit/ Hyperactivity Disorder Rating Scale 
AE 
adverse event 
AIMS 
Abnormal Involuntary Movement Scale 
ATC 
Anatomic Therapeutic Chemical 
BARS 
Barnes Akathisia Rating Scale  
β-hCG 
beta-subunit of human chorionic gonadotropin 
BMI 
Body Mass Index 
CDRS-R 
Children's Depression Rating Scale, Revised 
CFR 
Code of Federal Regulations 
CGAS 
Clinician-rated Children’s Global Assessment Scale 
CGI-BP-S 
Clinical Global Impression Bipolar Version – Severity 
CGI-S 
Clinical Global Impression-Severity Scale 
CGSQ 
Caregiver Strain Questionnaire 
CNS 
central nervous system 
CRA 
clinical research associate 
CRO 
contract research organization 
C-SSRS 
Columbia Suicide Severity Rating Scale 
CY-BOCS 
Children's Yale-Brown Obsessive Compulsive Scales 
CYP 
cytochrome P 
DSMB 
Data and Safety Monitoring Board 
DSM-IV-TR 
Diagnostic and Statistical Manual of Mental Disorders, 4th 
Edition, Text Revision 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
Electronic data capture 
EPS 
extrapyramidal symptoms  

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Abbreviation  
Term 
FSH 
Follicle stimulating hormone 
GCP 
Good Clinical Practice 
HbA1c 
Hemoglobin A1c 
HIV 
human immunodeficiency virus 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
IXRS 
Interactive Voice/Web Response System 
MAO 
monoamine oxidase 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
milligram 
PANSS 
Positive and Negative Syndrome Scale 
PARS 
Pediatric Anxiety Rating Scale 
PDD 
Pervasive developmental disorders 
PQ-LES-Q 
Pediatric Quality of Life Enjoyment and Satisfaction 
Questionnaire 
QD 
once-daily 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SAS 
Simpson-Angus Scale 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TEAE 
treatment-emergent adverse event 
UKU 
Udvalg for Kliniske Undersogelser Side Effect Rating Scale 
WHO 
World Health Organization  
YMRS 
Young Mania Rating Scale 
• CRF: A printed, optical, or electronic document designed to record all of the protocol 
required information to report to the sponsor for each study subject. 
• Screened Subject: Any subject who signed the study specific informed consent. 
• Screen Failures: Any subject who signed the study specific informed consent but 
either failed to meet study requirements during screening or met study requirements 
at screening but was not enrolled. 

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• Study Drug (or study medication): Term to cover investigational drug.  
• Treatment Phase: The period of the study in which the study drug is administered. 
• Enrolled Subject: Any subject who was successfully screened and enter the treatment 
phase of the study. 
• Completed Subject: Any subject who participated throughout the duration of the 
study, up to and including the end of study visit. 
• Early Termination Subject: Any subject who was successfully screened and enrolled 
into the treatment phase of the study, but did not complete the study. 

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4. 
INTRODUCTION 
4.1. 
Previous Human Experience in Pediatric Subjects 
There has been 1 completed pediatric clinical study evaluating the safety, tolerability, and 
pharmacokinetics of single and multiple doses of lurasidone in adolescents (12-17 years of age) 
and children (6-11 years of age) with schizophrenia spectrum, bipolar spectrum, autistic 
spectrum disorder, or other psychiatric disorders (Study D1050300). 
Preliminary results from this study revealed that exposure in the pediatric population (6-17 years 
of age) are similar to observed exposure in adults across the dose range (20-160 mg). The most 
frequently observed AEs (≥10%) across the dose range in this population were somnolence 
(42%), sedation (18%), nausea (17%), and vomiting (15%). 
4.2. 
Study Rationale 
Lurasidone is a novel compound being developed by Sunovion Pharmaceuticals Inc, and is an 
approved agent for the treatment of adult patients with schizophrenia. Lurasidone has a unique 
chemical structure that differs from conventional and atypical antipsychotic agents. Lurasidone is 
a novel compound with high affinities for dopamine D2, serotonin 5-HT2A and 5-HT7 receptors, 
moderate affinity for serotonin 5-HT1A and noradrenaline α2C and α2A receptors, and little or no 
affinity for histamine H1 and muscarinic M1 receptors which are thought to be responsible for 
some important side effects (weight gain, sedation) and worsening of the cognitive function. 
Clinical studies in adults with schizophrenia treated with lurasidone have shown significant 
beneficial effects on the amelioration of positive and negative symptoms with a minimal effect 
on weight gain, glucose metabolism, and lipid parameters. 
Based on its pharmacologic profile as well as clinical studies in adult subjects with schizophrenia 
and bipolar depression, lurasidone is expected to be associated with few extrapyramidal 
symptoms (EPS) and to be effective in ameliorating a broad range of symptoms in adolescents 
with schizophrenia, autistic disorder, and bipolar depression. 
This open-label extension study is designed to evaluate the longer-term safety, tolerability, and 
effectiveness of lurasidone over 104 weeks for the treatment of pediatric patients that have 
completed a previous lurasidone study. The 104-week study duration will provide an adequate 
timeframe within which to evaluate the longer-term effects of lurasidone in this patient 
population. 
4.3. 
Dose Justification 
Based on the therapeutic dose ranges evaluated in prior lurasidone clinical studies, doses of 
20, 40, 60 or 80 mg/day will be used in this study. Lurasidone will be taken with food for 
optimal exposure to the administered dose. The dose of lurasidone may be adjusted to optimize 
efficacy and tolerability, as deemed clinically appropriate. 

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5. 
STUDY OBJECTIVES  
5.1. 
Primary Objective 
To evaluate the long-term safety, tolerability, and effectiveness of lurasidone (20, 40, 60 or 
80 mg/day, flexibly dosed) in pediatric subjects who have completed a prior lurasidone study. 
5.2. 
Secondary Objectives 
For all subjects: 
• Proportions of subjects with adverse events (AEs), discontinuations due to AEs, and 
serious AEs (SAEs).  
For subjects continued from Study D1050301, the following will be assessed: 
• Change in Positive and Negative Syndrome Scale (PANSS) total, positive, negative, 
general psychopathology, and excitability subscale scores;  
• Change in the Clinical Global Impression – Severity (CGI-S); 
• Change in the Clinician-rated Children’s Global Assessment Scale (CGAS);  
• Change in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire 
(PQ-LES-Q). 
For subjects continued from Study D1050325, the following will be assessed: 
• Change in Aberrant Behavior Checklist (ABC) irritability subscale, and the following 
subscale scores (hyperactivity, stereotypy, inappropriate speech, and lethargy/social 
withdrawal); 
• Change in the Clinical Global Impression – Severity (CGI-S);  
• Change in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) 
modified for pervasive developmental disorders (PDDs); 
• Change in the Caregiver Strain Questionnaire (CGSQ). 
For subjects continued from Study D1050326, the following will be assessed: 
• Change in the Children's Depression Rating Scale, Revised (CDRS-R); 
• Change in the Clinical Global Impression Bipolar Version – Severity (CGI-BP-S); 
• Change in the Clinician-rated Children’s Global Assessment Scale (CGAS);  
• Change in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire 
(PQ-LES-Q); 
• Change in anxiety symptoms as measured by the Pediatric Anxiety Rating Scale 
(PARS); 
• Change in attention-deficit/hyperactivity symptoms as measured by the Attention-
Deficit/ Hyperactivity Disorder Rating Scale (ADHD-RS) total score. 

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6. 
STUDY ENDPOINTS 
6.1. 
Safety Assessments 
All Subjects: 
• Treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and 
serious AEs (SAEs); 
• Laboratory tests, vital signs, body weight and body mass index (BMI), waist 
circumference, physical examination, height (as measured by stadiometer), 
electrocardiogram (ECG), hormonal parameters; 
• Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), 
Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS); 
• Tanner staging, and menstrual cyclicity (female subjects). 
For subjects continued from Study D1050301 and D1050326: 
• Columbia Suicide Severity Rating Scale (C-SSRS); 
• Composite Score of the CogState Computerized Cognitive Test Battery; 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU). 
For subjects continued from Study D1050326: 
• Young Mania Rating Scale (YMRS) score. 
6.2. 
Effectiveness Assessments 
For subjects continued from Study D1050301: 
• Positive and Negative Syndrome Scale (PANSS); 
• Clinical Global Impression-Severity (CGI-S) scale; 
• Clinician-rated Children’s Global Assessment Scale (CGAS); 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q). 
For subjects continued from Study D1050325: 
• Aberrant Behavior Checklist (ABC); 
• Clinical Global Impression-Severity (CGI-S) scale; 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs); 
• Caregiver Strain Questionnaire (CGSQ). 
For subjects continued from Study D1050326: 
• Children's Depression Rating Scale, Revised (CDRS-R); 
• Clinical Global Impression Bipolar Version -Severity (CGI-BP-S) scale; 

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• Clinician-rated Children’s Global Assessment Scale (CGAS); 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q); 
• Pediatric Anxiety Rating Scale (PARS); 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS). 

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7. 
INVESTIGATIONAL PLAN 
7.1. 
Overall Study Design 
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term 
safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in 
pediatric subjects who have completed a 6-week treatment period in one of the preceding studies, 
D1050301, D1050325, or D1050326.   
Subjects who complete participation in one of the preceding studies, D1050301, D1050325 or 
D1050326, will be eligible for enrollment in this study. Informed consent/assent will be obtained 
from all subjects (where developmentally appropriate) before any study procedures are 
performed. Subjects who meet entry criteria will transition to this study directly from Study 
D1050301, D1050325 or D1050326. All subjects will be treated with flexibly dosed lurasidone 
during the trial. 
A reliable informant (eg, parent, legal guardian, or caregiver) of the subject must accompany the 
subject at each visit. For subjects entering from Study D1050325, the reliable caregiver will also 
oversee the administration of the study drug throughout the study. 
All eligible subjects will be treated with lurasidone 40 mg/day for Days 1-7. Beginning with 
Day 8, dose adjustments (20, 40, 60 or 80 mg/day) will be permitted, based on investigator 
judgment, to optimize tolerability and effectiveness.  
Dose adjustment of study drug should occur at the regularly scheduled visits and in increments 
or decrements of 1 dose level. However, dose reductions for tolerability or safety purposes may 
occur beginning on Day 2, based on investigator judgment. These dose reductions may be 
between study visits and at more than 1 dose level at a time (maximum of 2 dose levels at a 
time). If dose reductions are required between regular study visits, the subject must return to the 
study site for an unscheduled visit to receive new medication kits and return all used/unused 
medication kits at the time of dose adjustment.  
Safety and effectiveness assessments will be conducted at scheduled visits during the study. 
A follow-up visit will occur 1 week post last dose of study drug. 
A DSMB will review safety and clinical outcome data including data on AEs and SAEs at 
regular intervals until the D1050301, D1050325, and D1050326 studies are complete and as long 
as necessary for the D1050302 study, as determined by the Sponsor. The DSMB will be 
independent of the Sponsor, contract research organization (CRO), and the investigators and will 
be empowered to recommend stopping the study due to safety concerns, but not for efficacy or 
futility. The membership of the DSMB and its mandate is denoted in the DSMB charter. 
A study schematic is presented below in Figure 1. Details of study assessments and other 
procedures to be performed at each visit are presented in Table 3, Schedule of Assessments, and 
Section 11, Treatment Plan. 

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Figure 1: 
Study Schematic 
D1050301 Adolescent 
Schizophrenia Study
D1050325 Children and 
Adolescent Autistic 
Disorder Study
Lurasidone flexibly dosed
20, 40, 60, or 80 mg/day
Enrollment into the 
D1050302 
Extension Study
Follow-up
24 Months
1 Week post last dose
D1050326 Children and 
Adolescent Bipolar 
Depression Study
 
 
7.2. 
Study Termination Criteria 
The study may be terminated at any time by the sponsor for any reason. 
 

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Table 3: 
Schedule of Assessments Enrollment to Week 40 
Study Visit Number 
Study Visit Week (±3 days) 
V 1E 
V 2E 
V 3E 
V 4E 
V 5E 
V 6E 
V 7E 
V 8E 
V 9E 
V 10E 
V 11E 
V 12E 
V 13E 
Day 1 
W2 
W4 
W6 
W8 
W12 
W16 
W20 
W24 
W28 
W32 
W36 
W40 
Obtain informed consent/assent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Interactive Voice/Web Response System 
(IXRS) subject registry/visit 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Dispense study medication  
X 
Xa 
X 
Xa 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study drug accountability/assess compliance 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Clinical and Laboratory Evaluations: ALL 
SUBJECTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior/concomitant medication review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse event (AE) monitoring 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical examination 
These 
clinical 
evaluations 
were to 
have been 
performed 
at Study 
Visit 
Number 9 
in study 
D1050301 
or 
D1050325 
or at Study 
Visit 
Number 8 
in study 
D1050326 
and will 
serve as the 
baseline 
evaluations 
for this 
study. 
 
 
 
 
 
 
 
 
X 
 
 
X 
Height as measured by stadiometer 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Tanner staging 
 
 
 
 
 
 
 
 
X 
 
 
X 
Menstrual cyclicity (female subjects) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital signsb 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Weight  
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Waist circumference measurement 
 
 
 
 
X 
 
 
 
X 
 
 
X 
Electrocardiogram (ECG) 
 
 
 
 
 
 
 
 
X 
 
 
 
Hematology, chemistry, and urinalysis 
 
 
 
 
X 
 
 
 
X 
 
 
 
Hormonal Parametersc 
 
 
 
 
X 
 
 
 
X 
 
 
 
Serum prolactin 
 
 
 
 
X 
 
 
 
X 
 
 
 
Glycosylated hemoglobin (HbA1c) 
 
 
 
 
X 
 
 
 
X 
 
 
 
Glucose and lipid paneld 
 
 
 
 
X 
 
 
 
X 
 
 
 
Serum insulin and C-reactive protein 
 
 
 
 
X 
 
 
 
X 
 
 
 

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Study Visit Number 
Study Visit Week (±3 days) 
V 1E 
V 2E 
V 3E 
V 4E 
V 5E 
V 6E 
V 7E 
V 8E 
V 9E 
V 10E 
V 11E 
V 12E 
V 13E 
Day 1 
W2 
W4 
W6 
W8 
W12 
W16 
W20 
W24 
W28 
W32 
W36 
W40 
Urine drug screen 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Urine β-hCGe, f 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Simpson-Angus Scale (SAS) 
These 
clinical 
evaluations 
were to 
have been 
performed 
at Study 
Visit 
Number 9 
in study 
D1050301 
or 
D1050325 
or at Study 
Visit 
Number 8 
in study 
D1050326 
and will 
serve as the 
baseline 
evaluations 
for this 
study. 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Barnes Akathisia Rating Scale (BARS) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abnormal Involuntary Movement Scale 
(AIMS) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Clinical Evaluations:  
SUBJECTS from D1050301 ONLY 
 
 
 
 
 
 
 
 
 
 
 
 
Children’s Global Assessment Scale (CGAS) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Clinical Global Impression – Severity (CGI-S) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Pediatric Quality of Life Enjoyment and 
Satisfaction Questionnaire (PQ-LES-Q) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Udvalg for Kliniske Undersogelser Side Effect 
Rating Scale (UKU) 
X 
 
X 
 
X 
 
 
 
X 
 
 
X 
Columbia Suicide Severity Rating Scale  
(C-SSRS) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Positive and Negative Syndrome Scale 
(PANSS) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
CogState Computerized Cognitive Test Battery 
 
 
 
 
X 
 
 
 
X 
 
 
 
Clinical Evaluations:  
SUBJECTS from D1050325 ONLY 
 
 
 
 
 
 
 
 
 
 
 
 
Aberrant Behavior Checklist (ABC) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Clinical Global Impression – Severity (CGI-S) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Children's Yale-Brown Obsessive Compulsive 
Scales (CY-BOCS) modified for pervasive 
developmental disorders (PDDs) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Caregiver Strain Questionnaire (CGSQ) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 

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Study Visit Number 
Study Visit Week (±3 days) 
V 1E 
V 2E 
V 3E 
V 4E 
V 5E 
V 6E 
V 7E 
V 8E 
V 9E 
V 10E 
V 11E 
V 12E 
V 13E 
Day 1 
W2 
W4 
W6 
W8 
W12 
W16 
W20 
W24 
W28 
W32 
W36 
W40 
Clinical Evaluations:  
SUBJECTS from D1050326 ONLY 
These 
clinical 
evaluations 
were to 
have been 
performed 
at Study 
Visit 
Number 9 
in study 
D1050301 
or 
D1050325 
or at Study 
Visit 
Number 8 
in study 
D1050326 
and will 
serve as the 
baseline 
evaluations 
for this 
study. 
 
 
 
 
 
 
 
 
 
 
 
 
Children’s Depression Rating Scale, Revised 
(CDRS-R) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Clinical Global Impression-Bipolar Version, 
Severity of Illness (CGI BP-S) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Children’s Global Assessment Scale (CGAS) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Young Mania Rating Scale (YMRS) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Pediatric Quality of Life Enjoyment and 
Satisfaction Questionnaire (PQ-LES-Q) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Columbia Suicide Severity Rating Scale  
(C-SSRS) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Udvalg for Kliniske Undersogelser Side Effect 
Rating Scale (UKU) 
X 
 
X 
 
X 
 
 
 
X 
 
 
X 
Pediatric Anxiety Rating Scale (PARS) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
Attention-Deficit/Hyperactivity Disorder Rating 
Scale (ADHD-RS) 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
CogState Computerized Cognitive Test Battery 
 
 
 
 
X 
 
 
 
X 
 
 
 
Abbreviations: V = Visit; Wk = Week 
a Study drug will be dispensed only if a dose change is required. 
b Vital sign measurements to include orthostatic changes in blood pressure and heart rate. 
c Hormonal Parameters include the following measures: follicle stimulating hormone; luteinizing hormone; testosterone (male subjects only); estradiol (female subjects only). 
d Subjects will fast for laboratory tests.  
e Any positive urine β-hCG test will be confirmed by serum β-hCG. 
f Females subjects ≥ 11 years of age only. 
If a subject discontinues from the study, all Visit 29E procedures will be performed at the discontinuation visit, within 48 hours of the last dose of study medication.  

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Table 4: 
Schedule of Assessments - Week 44 to 92 
Study Visit Number 
Study Visit Week (±3 days) 
V 14E 
V 15E 
V 16E 
V 17E 
V 18E 
V 19E 
V 20E 
V 21E 
V 22E 
V 23E 
V 24E 
V 25E 
V 26E 
W44  
W48  
W52  
W56 
W60  
W64  
W68 
W72 
W76 
W80 
W84 
W88 
W92 
Interactive Voice/Web Response System (IXRS) 
subject registry/visit 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Dispense study medication  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study drug accountability/assess compliance 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Clinical and Laboratory Evaluations: ALL 
SUBJECTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior/concomitant medication review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse event monitoring 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical examination 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Height as measured by stadiometer 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Tanner staging 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Menstrual cyclicity (female subjects) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital signsa 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Weight  
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Waist circumference measurement 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Electrocardiogram (ECG) 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Hematology, chemistry, and urinalysis 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Hormonal Parametersb 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Serum prolactin 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Glycosylated hemoglobin (HbA1c) 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Glucose and lipid panelc 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Serum insulin and C-reactive protein 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Urine drug screen 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Urine β-hCGd, e 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

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Study Visit Number 
Study Visit Week (±3 days) 
V 14E 
V 15E 
V 16E 
V 17E 
V 18E 
V 19E 
V 20E 
V 21E 
V 22E 
V 23E 
V 24E 
V 25E 
V 26E 
W44  
W48  
W52  
W56 
W60  
W64  
W68 
W72 
W76 
W80 
W84 
W88 
W92 
Simpson-Angus Scale (SAS) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Barnes Akathisia Rating Scale (BARS) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abnormal Involuntary Movement Scale (AIMS) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Clinical Evaluations:  
SUBJECTS from D1050301 ONLY 
 
 
 
 
 
 
 
 
 
 
 
 
 
Children’s Global Assessment Scale (CGAS) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Clinical Global Impression – Severity Scale 
(CGI-S) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Pediatric Quality of Life Enjoyment and 
Satisfaction Questionnaire (PQ-LES-Q) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Udvalg for Kliniske Undersogelser Side Effect 
Rating Scale (UKU) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Columbia Suicide Severity Rating Scale  
(C-SSRS) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Positive and Negative Syndrome Scale (PANSS) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
CogState Computerized Cognitive Test Battery 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Clinical Evaluations:  
SUBJECTS from D1050325 ONLY 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aberrant Behavior Checklist (ABC) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Clinical Global Impression – Severity Scale 
(CGI-S) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Children's Yale-Brown Obsessive Compulsive 
Scales (CY-BOCS) modified for pervasive 
developmental disorders (PDDs) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Caregiver Strain Questionnaire (CGSQ) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Clinical Evaluations:  
SUBJECTS from D1050326 ONLY 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Visit Number 
Study Visit Week (±3 days) 
V 14E 
V 15E 
V 16E 
V 17E 
V 18E 
V 19E 
V 20E 
V 21E 
V 22E 
V 23E 
V 24E 
V 25E 
V 26E 
W44  
W48  
W52  
W56 
W60  
W64  
W68 
W72 
W76 
W80 
W84 
W88 
W92 
Children’s Depression Rating Scale, Revised 
(CDRS-R) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Clinical Global Impression-Bipolar Version, 
Severity of Illness (CGI BP-S) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Children’s Global Assessment Scale (CGAS) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Young Mania Rating Scale (YMRS) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Pediatric Quality of Life Enjoyment and 
Satisfaction Questionnaire (PQ-LES-Q) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Columbia Suicide Severity Rating Scale  
(C-SSRS) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Udvalg for Kliniske Undersogelser Side Effect 
Rating Scale (UKU) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Pediatric Anxiety Rating Scale (PARS) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Attention-Deficit/Hyperactivity Disorder Rating 
Scale (ADHD-RS) 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
CogState Computerized Cognitive Test Battery 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
Abbreviations: V = Visit; Wk = Week 
a Vital sign measurements to include orthostatic changes in blood pressure and heart rate. 
b Hormonal Parameters include the following measures: follicle stimulating hormone; luteinizing hormone; testosterone (male subjects only); estradiol (female subjects only). 
c Subjects will fast for laboratory tests.  
d Any positive urine β-hCG test will be confirmed by serum β-hCG. 
e Females subjects ≥ 11 years of age only. 
If a subject discontinues from the study, all Visit 29E procedures will be performed at the discontinuation visit, within 48 hours of the last dose of study medication.  

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Table 5: 
Schedule of Assessments - Week 96 to 105 
Study Visit Number 
Study Visit Week (±3 days) 
V 27E 
V 28E 
EOS/ET 
V 29E a 
F/U 
V 30E 
Wk96  
Wk100  
Wk104  
Wk105 
Interactive Voice/Web Response System (IXRS) subject 
registry/visit 
X 
X 
X 
X 
Dispense study medication  
X 
X 
 
 
Study drug accountability/assess compliance 
X 
X 
X 
 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
 
 
 
 
Prior/concomitant medication review 
X 
X 
X 
X 
Adverse event monitoring 
X 
X 
X 
X 
Physical examination 
 
 
X 
 
Height as measured by stadiometer 
 
 
X 
 
Tanner staging 
 
 
X 
 
Menstrual cyclicity (female subjects) 
X 
X 
X 
X 
Vital signsb 
X 
X 
X 
X 
Weight  
 
 
X 
 
Waist circumference measurement 
 
 
X 
 
Electrocardiogram (ECG) 
 
 
X 
 
Hematology, chemistry, and urinalysis 
 
 
X 
 
Hormonal Parametersc 
 
 
X 
 
Serum prolactin 
 
 
X 
 
Glycosylated hemoglobin (HbA1c) 
 
 
X 
 
Glucose and lipid paneld 
 
 
X 
 
Serum insulin and C-reactive protein 
 
 
X 
 
Urine drug screen 
X 
X 
X 
 
Urine β-hCGe, f 
X 
X 
X 
X 

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Study Visit Number 
Study Visit Week (±3 days) 
V 27E 
V 28E 
EOS/ET 
V 29E a 
F/U 
V 30E 
Wk96  
Wk100  
Wk104  
Wk105 
Simpson-Angus Scale (SAS) 
X 
X 
X 
X 
Barnes Akathisia Rating Scale (BARS) 
X 
X 
X 
X 
Abnormal Involuntary Movement Scale (AIMS) 
X 
X 
X 
X 
Clinical Evaluations:  
SUBJECTS from D1050301 ONLY 
 
 
 
 
Children’s Global Assessment Scale (CGAS) 
 
 
X 
 
Clinical Global Impression – Severity Scale (CGI-S) 
X 
X 
X 
 
Pediatric Quality of Life Enjoyment and Satisfaction 
Questionnaire (PQ-LES-Q) 
 
 
X 
 
Udvalg for Kliniske Undersogelser Side Effect Rating 
Scale (UKU) 
 
 
X 
 
Columbia Suicide Severity Rating Scale  
(C-SSRS) 
X 
X 
X 
X 
Positive and Negative Syndrome Scale (PANSS) 
 
 
X 
 
CogState Computerized Cognitive Test Battery 
 
 
X 
 
Clinical Evaluations:  
SUBJECTS from D1050325 ONLY 
 
 
 
 
Aberrant Behavior Checklist (ABC) 
 
 
X 
 
Clinical Global Impression – Severity Scale (CGI-S) 
X 
X 
X 
 
Children's Yale-Brown Obsessive Compulsive Scales (CY-
BOCS) modified for pervasive developmental disorders 
(PDDs) 
 
 
X 
 
Caregiver Strain Questionnaire (CGSQ) 
 
 
X 
 
Clinical Evaluations:  
SUBJECTS from D1050326 ONLY 
 
 
 
 
Children’s Depression Rating Scale, Revised (CDRS-R) 
 
 
X 
 
Clinical Global Impression-Bipolar Version, Severity of 
X 
X 
X 
 

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Study Visit Number 
Study Visit Week (±3 days) 
V 27E 
V 28E 
EOS/ET 
V 29E a 
F/U 
V 30E 
Wk96  
Wk100  
Wk104  
Wk105 
Illness (CGI BP-S) 
Children’s Global Assessment Scale (CGAS) 
 
 
X 
 
Young Mania Rating Scale (YMRS) 
 
 
X 
 
Pediatric Quality of Life Enjoyment and Satisfaction 
Questionnaire (PQ-LES-Q) 
 
 
X 
 
Columbia Suicide Severity Rating Scale  
(C-SSRS) 
X 
X 
X 
X 
Udvalg for Kliniske Undersogelser Side Effect Rating 
Scale (UKU) 
 
 
X 
 
Pediatric Anxiety Rating Scale (PARS) 
 
 
X 
 
Attention-Deficit/Hyperactivity Disorder Rating Scale 
(ADHD-RS) 
 
 
X 
 
CogState Computerized Cognitive Test Battery 
 
 
X 
 
Abbreviations: V = Visit; Wk = Week; F/U = follow-up 
a If a subject discontinues from the study, all Visit 29E procedures will be performed at the discontinuation visit, within 48 hours of the last dose of study medication.  
b Vital sign measurements to include orthostatic changes in blood pressure and heart rate. 
c Hormonal Parameters include the following measures: follicle stimulating hormone; luteinizing hormone; testosterone (male subjects only); estradiol (female subjects only). 
d Subjects will fast for laboratory tests.  
e Any positive urine β-hCG test will be confirmed by serum β-hCG. 
f Females subjects ≥ 11 years of age only. 

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8. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
The following inclusion/exclusion criteria must be met prior to enrolling the subject into the 
study. 
8.1. 
Subject Inclusion Criteria 
1. Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual 
capacity to understand the study and support subjects’ participation in the study 
procedures must be obtained for subjects who are not emancipated. In accordance with 
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements, 
the subject will complete an informed assent when developmentally appropriate, to 
participate in the study before conduct of any study-specific procedures. 
2. Subject has completed Study D1050301 (Visit 9); 
OR 
Subject has completed Study D1050325 (Visit 9); 
OR 
Subject has completed Study D1050326 (Visit 8). 
 
3. Subject is judged by the investigator to be appropriate for participation in a 104-week 
clinical trial in an outpatient setting involving open-label lurasidone treatment, and is able 
to comply with the protocol. 
4. A reliable informant (eg, parent, legal guardian, or caregiver) must be available to 
accompany the subject at each visit. For subjects entering from Study D1050325, the 
reliable caregiver must also oversee the administration of the study drug throughout the 
study. 
5. Females who participate in this study: 
• are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) 
-OR- 
• practices true abstinence (consistent with lifestyle) and must agree to remain abstinent 
from signing informed consent to at least 7 days after the last dose of study drug has 
been taken; 
-OR- 
• are sexually active and willing to use a medically effective method of birth control 
(eg, male using condom and female using condom, diaphragm, contraceptive sponge, 
spermicide, contraceptive pill, or intrauterine device) from signing informed consent 
to at least 7 days after the last dose of study drug has been taken. 
6. Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an 
effective method of birth control (eg, male using condom and female using condom, 
diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) 

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from signing informed consent to at least 7 days after the last dose of study drug has been 
taken.  
8.2. 
Subject Exclusion Criteria 
1. Subject is considered by the investigator to be at imminent risk of suicide. 
2. Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive 
dyskinesia, or any other moderate or severe movement disorder. Severity to be 
determined by the investigator. 

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9. 
TREATMENT OF SUBJECTS 
9.1. 
Concomitant Medications 
Any medication or non-pharmacological therapy that is taken by or administered to the subject at 
any point during the course of this study must be recorded in the electronic case report form 
(eCRF). The entry must include the dose, regimen, route, indication, and dates of use. 
Potent inducers or inhibitors of the CYP3A4 enzyme system (Appendix B) and any medications 
that consistently prolong the QTc interval are prohibited. In addition, the use of herbal 
supplements (for psychotropic reasons, eg, Gingko Biloba, Kava Kava, St. John’s Wort, etc.) or 
other complementary or alternative medications except melatonin during the study are not 
permitted. 
Initiation of new non-pharmacologic therapy (eg, a new course of psychotherapy or behavior 
modification) is permitted during the study. Subjects who have participated in ongoing 
psychotherapy or other non-pharmacological treatment during Study D1050301, D1050325, or 
D1050326 will be permitted to continue this treatment during the study. 
9.1.1. 
Concomitant Non-psychotropic Medications 
Non-psychotropic medications may be used to treat mild, chronic medical conditions if the dose 
and regimen have been stable (± 25%) during Study D1050301, D1050325, or D1050326. 
β-adrenergic antagonists used to treat stable hypertension can be continued throughout the study. 
In addition, use of non-prescription pain medications (eg, acetaminophen or ibuprofen) are 
allowed provided these medications do not have a propensity for psychotropic effects and do not 
interfere with the evaluation of study drug. Medications for short-term treatment of a medical 
condition (no more than 14 days) are allowed provided that the medications are not CYP3A4 
inhibitors/inducers and do not consistently prolong the QTc interval. 
9.1.2. 
Concomitant Psychotropic Medications  
Subjects may be treated with any approved benzodiazepines or antidepressants provided that the 
medications are not potent CYP3A4 inhibitors/inducers (Appendix B), during the course of the 
study, at the discretion of the investigator in a manner consistent with labeling recommendations 
and conventional medical practice. Monoamine oxidase inhibitors (MAOI) and additional 
antipsychotic medications (with the exception of lurasidone) will be prohibited.  
Treatment with stimulants (provided that the medications are not potent CYP3A4 
inhibitors/inducers), guanfacine or atomoxetine will be permitted during the course of the study 
for treatment of attentional deficits, at the discretion of the investigator in a manner consistent 
with labeling recommendations and conventional medical practice. 
Treatment with benztropine (≤ 6 mg/day) will be permitted as needed for movement disorders. In 
cases where benztropine is not available, or a subject has had an inadequate response or 
intolerability to benztropine treatment, the following medications may be used to treat acute 
EPS: biperiden (≤ 16 mg/day) or trihexyphenidyl (≤ 15 mg/day) or diphenhydramine 
(≤ 100 mg/day for subjects entering from Study D1050301 or Study D1050326; ≤ 50 mg/day for 
subjects entering from Study D1050325). Treatment with propranolol (≤ 120 mg/day) will be 

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permitted as needed for akathisia. Medications used to treat movement disorders should not be 
given prophylactically. 
Concomitant use of lorazepam, or equivalent benzodiazepine, is permitted at the discretion of the 
investigator (≤ 6 mg/day or equivalent dose) for intolerable anxiety/agitation, as clinically 
indicated. In regions where lorazepam or other specified medications are not available, another 
similar agent at equivalent doses will be permitted as specified by the Medical Monitor and/or 
the Operations Manual. Benzodiazepines administered orally or as a rapid acting IM injection 
should be used sparingly, and only when clinically required per investigator judgment. The date 
and time of last dose of lorazepam (or equivalent benzodiazepine) must be recorded at each visit. 
Subjects should be encouraged to avoid taking these medications within 8 hours prior to 
scheduled study assessments. 
Temazepam (≤ 30 mg/day), eszopiclone (≤ 3 mg/day), zaleplon (≤ 20mg/day), zolpidem 
(≤ 10 mg/day for males; ≤ 5 mg/day for females), zolpidem CR (≤ 12.5 mg/day for males; 
≤ 6.25 mg/day for females), diphenhydramine (≤ 100 mg/day for subjects entering from Study 
D1050301 or D1050326; ≤ 50 mg/day for subjects entering from Study D1050325), melatonin 
(≤ 5 mg/day), or clonidine immediate release (≤ 0.1 mg/day) may be administered at bedtime for 
insomnia, as needed. For those subjects taking melatonin, over the counter melatonin should be 
used; combination melatonin products are not allowed. Sedative-hypnotic agents should be 
administered no more than once nightly and should not be used in combination. 
Since the list of prohibited potent CYP3A4 inhibitors and inducers (Appendix B) is not 
comprehensive, investigators should use medical judgment when a subject presents with a 
medication not on the list or consult with the Medical Monitor for clarification. 
9.2. 
Treatment Compliance 
All subjects and caregivers will be reminded at each study visit of the importance of strict 
compliance with taking study medication as directed, with food. Compliance with study 
medication must be monitored closely at each visit. Subjects will be instructed to bring all 
unused study medication with them to each visit. Subjects missing more than 25% or taking 
more than 125% of scheduled doses between visits must be immediately reported to and 
discussed with the Medical Monitor. 
9.3. 
Hospitalization 
Subjects who were hospitalized at the conclusion of the previous core study (either D1050301 or 
D1050326) can continue to be hospitalized for up to 14 days in this study at the discretion of the 
investigator. The investigator must evaluate the subject to determine the length of hospitalization 
based on his/her clinical judgment. After these initial 14 days, subjects must be transitioned to an 
outpatient setting for the remainder of the study. If the subject cannot be transitioned to an 
outpatient setting, they must be discontinued from the study.  
If a subject discontinues and is clinically unstable, additional hospitalization (beyond the original 
14 days allowed) may be allowed on a case-by-case basis with pre-approval of the Medical 
Monitor. 
For hospitalized subjects, they must be clinically stable, in the judgment of the investigator, to 
warrant discharge to the appropriate living environment. In making a discharge determination, 
investigators should also consider the following additional factors: appropriateness for outpatient 

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treatment; a stable residence with adequate caregiver support; and the ability of the subject to be 
compliant with study medications and study visits. 

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10. 
STUDY DRUG MATERIALS AND MANAGEMENT 
10.1. 
Description of Study Drug 
The study drug is lurasidone 20 mg tablets and lurasidone 40 mg tablets. 
Table 6: 
Investigational Product 
Investigational Drug: 
Lurasidone  
Active Ingredient: 
Lurasidone hydrochloride (HCl) 
Formulation: 
Film-coated lurasidone 20 mg active tablets and film-coated 
lurasidone 40 mg active tablets. 
Frequency: 
20 mg, 40 mg, 60 mg, or 80 mg once daily (QD)  
Packaged as: 
20 mg or 40 mg tablets in Aluminum-Aluminum blister package 
Manufactured by: 
Dainippon Sumitomo Pharma Co., Ltd. 
Storage Conditions: 
Store between 15-25ºC (59-77ºF). Protect from light and moisture 
Packaging Description: 
Aluminum-Aluminum blister package. 
10.2. 
Study Drug Packaging and Labeling 
Supplies will be packaged in blister cards as described below. Study medication will be labeled 
with the clinical trial number and all appropriate investigational labeling requirements. 
10.2.1. 
Blister Cards 
All study medication will be packaged in uniquely identifiable 7-day supply (plus 2 days) blister 
cards. At each dispensing visit a subject will receive a 4-week carton which contains four blister 
cards. The 20 mg per day and 40 mg per day blister cards will contain one column and 9 rows. 
The 60 mg per day and 80 mg per day blister cards will contain two columns and 9 rows. 
Subjects assigned to the 20 mg per day or 40 mg per day dose will be requested to take 1 tablet 
(one row) each day, according to dosing instructions. Subjects assigned to the 60 mg per day or 
80 mg per day dose will be requested to take 2 tablets (one row), each day according to dosing 
instructions.  
The labeling and packaging of the study medication will be based on the guidance described in 
US Code of Federal Regulations, CFR 21, Part 312.6, Annex 13 and any other local applicable 
regulatory requirements. Container label text for study medication blister cards may include the 
following information listed in Table 7 below: 
 

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Table 7: 
Blister Card and Carton Label Example 
1) 
Med ID #: XXXXXX 
 
(IXRS identifying number)  
2) 
Protocol # D1050302 
3) 
Space for subject number (assigned by IXRS)  
4) 
Fill Count & Dosage Form  
5) 
Visit #   ___________ 
6) 
Packaging batch number XXXXXXXX-XX 
7) 
Expiry Date: MM/YYYY 
8) 
Investigator Information (contact information 
–if applicable) 
9) 
Sponsor Address:  
Sunovion Pharmaceuticals Inc.  
         One Bridge Plaza, Suite 510 
Fort Lee, NJ 07024, USA 
10) 
Directions for Use 
11) 
“Keep out of reach of children” 
statement  
12) 
For Oral Use 
13) 
Storage Conditions: Store 
between 15- 25°C (59-77°F). 
Protect from light and moisture. 
14) 
Caution: New Drug–Limited By 
Federal (or United States) Law to 
Investigational Use. 
15) 
For Clinical Trial Use Only and 
other Country Regulatory 
Requirements 
NOTE: Item 7, Expiration will not be on the US and Puerto Rico ONLY label 
10.3. 
Study Drug Storage 
The clinical study drug lurasidone should be stored between 15-25°C (59-77°F) and protected 
from light and moisture. The subject will be instructed to store the medication at room 
temperature. 
The study drug storage area will be monitored for temperature. A monitoring system recording 
temperature 24 hours a day, 7 days a week will be employed. Appropriate temperature records 
will be maintained. If the storage conditions fall outside of the indicated range, 15-25°C 
(59-77°F), the sponsor must be contacted to discuss the potential implications and any actions(s), 
if necessary. 
The investigator is responsible for the proper storage of the study drug according to the sponsor’s 
recommendations and all applicable federal and state regulatory guidelines. The investigator 
agrees not to dispense or store the study drug at any location other than that listed on Form FDA 
1572. 
10.4. 
Study Drug Dispensation and Handling 
A 4-week supply of study drug will be dispensed according to the visit schedule. The subject (or 
caregiver as appropriate) will be instructed to use the 2-day reserve if they miss their regularly 
scheduled visit. The subject (or caregiver as appropriate) will be instructed to return all unused 
study medication and empty blister cards to the clinical trial site at each visit. 

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10.5. 
Interactive Voice Response/Web Response System (IXRS) 
IXRS is an integrated phone and web, subject and drug management system. The interactive 
system that will assign unique subject numbers and medication identification numbers 
(Med ID #) corresponding to the appropriate cartons and blister cards. 
10.6. 
Administration 
The study drug will be dispensed by appropriately qualified site study staff. Under the 
supervision from the subject's caregiver, as appropriate, subjects will take the study drug 
following the directions given to them in the clinic. 
All study medication will be taken once daily in the evening by mouth with food (at least 
350 calories; eg, dinner) or within 30 minutes after eating. Subjects who, in the judgment of the 
investigator, are intolerant to evening dosing may be allowed for take study medication in the 
morning. Exceptions to the evening dosing of study medication are acceptable on a case-by case 
basis, and must be recorded appropriately in the eCRF. Subjects who change to morning dosing 
should continue morning dosing for the duration of the study. 
10.7. 
Study Drug Accountability 
Study drug must be received by the investigator or a designated person at the study site, handled 
and stored safely and properly, and kept in a secured location to which only the investigator 
and/or designated assistants have access. Study medication is to be dispensed only in accordance 
with the protocol. 
The investigator (or qualified designee) is responsible for maintaining accurate records of the 
study drug received from the Sponsor, the amount dispensed to and returned by the subjects, and 
the amount remaining at the conclusion of the study. At the end of the study, all study 
medication including unused, partially used, and empty blister cards must be returned to the 
Sponsor, or designee, after confirmation with the CRA. The investigator will be provided with 
instructions on the return of all study drug. The following information is to be included in the 
eCRF: visit medication dispensed, blister card number, time of dose, dosing start/stop dates, 
number of tablets dispensed, blister card return status and number of tablets returned. 
If the investigation is terminated, discontinued, suspended, or completed, all unused study drug 
will be returned to the Sponsor’s designee, unless other instructions are provided in writing by 
CRO/Sponsor. 
 

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11. 
TREATMENT PLAN 
11.1. 
Study Assessments 
11.1.1. 
Effectiveness 
Aberrant Behavior Checklist (ABC): The ABC is a symptom checklist for assessing problem 
behaviors of children and adults with intellectual disability and developmental disorders at home, 
in residential facilities, intermediate care facilities for individuals with intellectual disability, and 
work training center. It is also useful for classifying problem behaviors of these children and 
adolescent in educational settings, residential and community-based facilities, and developmental 
centers. The 58 items resolve into five subscales: (1) irritability and agitation, (2) lethargy and 
social withdrawal, (3) stereotypic behavior, (4) hyperactivity and noncompliance, and 
(5) inappropriate speech. The ABC irritability subscale contains 15 items that rate symptoms 
such as “injures self”, “aggressive to other children and adults”, “irritable”, “temper  outbursts”, 
“depressed mood”, “mood changes”, and “yells or screams inappropriately” on a scale ranging 
from 0 (not at all a problem) to 3 (severe). The checklist is completed by the subject’s 
parent/caregiver and the same parent/caregiver should complete all ABC assessments for a given 
subject whenever possible. The ABC-C (community) version will be used. 
Clinical Global Impression – Severity Scale (CGI-S): The CGI-S is a clinician-rated 
assessment of the subject’s current illness state on a 7 point scale, where a higher score is 
associated with greater illness severity (eg, schizophrenia or irritability associated with autism). 
Following a clinical interview, the CGI-S can be completed in 1-2 minutes (Guy 1976; Williams 
2000). The CGI-S will be administered by a qualified rater at the site and the same study site 
rater should perform all CGI-S assessments for a given subject whenever possible. 
Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for pervasive 
developmental disorders (PDDs): The Children's Yale-Brown Obsessive Compulsive Scale 
(CY-BOCS) modified for pervasive developmental disorders (PDDs) (Scahill, 2006) is a 
clinical-administered semistructured clinician rating that measures to measure the severity of 
obsessive-compulsive disorder. The modification for PDDs eliminates the obsessions checklist 
and severity scales of the CY-BOCS, while expanding the compulsions checklist to include 
repetitive behaviors more commonly seen in children with PDD. In addition, the modified for 
PDDs version relies more on parental input than on the child's input. The CY-BOCS will be 
administered by a qualified rater at the site and the same study site rater should perform all CY-
BOCS assessments for a given subject whenever possible. 
Children's Global Assessment Scale (CGAS): The CGAS is a clinician-rated assessment of the 
overall severity of disturbance in children, with a range of scores from 1 to 100. It anchors at 
10-point intervals include descriptors of functioning and psychopathology for each interval. A 
second version of the CGAS, designed for nonclinicians who have conducted a standardized 
diagnostic assessment of the child (usually in community surveys), was constructed similarly, 
except that the descriptors of psychopathology and functioning are written in lay terminology. 
The single numerical score representing severity of disturbance ranges from 1 (most impaired) to 
100 (healthiest). On the basis of the descriptors, raters are expected to synthesize their 
knowledge about the child’s social and symptomatic functioning and condense this information 

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into a score. For example, a score of 61–70 indicates that the child has some difficulty in a single 
area but is generally functioning pretty well. Scores above 70 are considered to be in the normal 
range, whereas scores on the low end of the continuum indicate a need for constant supervision 
(1–10) or considerable supervision (11–20). The CGAS will be administered by a qualified rater 
at the site and the same study site rater should perform all CGAS assessments for a given subject 
whenever possible. 
Caregiver Strain Questionnaire (CGSQ): The CGSQ is a caregiver reported assessment that 
assesses the extent to which caregivers are affected by the special demands associated with 
caring for a child with emotional and behavioral problems. The CGSQ is comprised of three 
subscales which range in severity from 1 to 5. Objective Strain refers to observable disruptions in 
family and community life (eg, interruption of personal time, lost work time, financial strain). 
Subjective Externalized Strain refers to negative feelings about the child such as anger, 
resentment, or embarrassment. Subjective Internalized Strain refers to the negative feelings that 
the caregiver experiences such as worry, guilt, or fatigue. Higher scores on each of these scales 
indicate greater strain. A Global Strain score is calculated by summing the three subscales (ie, 
Objective Strain, Subjective Externalized Strain, and Subjective Internalized Strain) to provide 
an indication of the total impact of the special demands on the family. Global Strain scores range 
from 3 to 15. As with the individual subscales, higher scores indicate greater strain. 
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q): The 
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) is a 15-item 
measure that assesses the quality of life in children and adolescents. This scale focuses on the 
child’s or adolescent’s views about general health, well-being, and feelings about the medical 
condition. Response categories range from “very poor” to “very good”. The PQ-LES-Q is a 
subject self-reported assessment. 
Positive and Negative Syndrome Scale (PANSS): The PANSS is an interview-based measure 
of the severity of psychopathology in adults with psychotic disorders. The measure is comprised 
of 30 items and 3 scales: the Positive scale assesses hallucinations, delusions, and related 
symptoms; the Negative scale assesses emotional withdrawal, lack of motivation, and similar 
symptoms; and the General Psychopathology scale addresses other symptoms such as anxiety, 
somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and 
above indicate the presence of progressively more severe symptoms, is used to score each item. 
Individual items are then summed to determine scores for the 3 scales, as well as a total score. A 
Composite scale score (Positive scale score minus Negative scale score) can also be calculated to 
show the relative valence of positive and negative symptoms. Total time required for the PANSS 
interview and scoring is approximately 30-40 minutes (Kay, 1994; Perkins, 2000; Opler, 1992). 
PANSS raters will be required to meet specific training and education criteria before they are 
certified to rate for this study. In addition, raters will receive specific training and education 
regarding all of the assessments prior to study initiation. The PANSS will be administered by a 
qualified rater at the site and the same study site rater should perform all PANSS assessments for 
a given subject whenever possible. 
Children's Depression Rating Scale, Revised (CDRS-R): The CDRS-R is a semi-structured, 
clinician-rated instrument designed for use with children and adolescents between the ages of 
6-17 years. It contains 17 ordinally-scaled items that evaluate the presence and severity of 
symptoms commonly associated with depression in childhood.  The CDRS-R score ranges from 

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17-113. The CDRS-R will be administered separately to the patient and to the caregiver. For 
each item, the rating that provides the best description of the patient will be selected by the 
clinician administering the interviews. The CDRS-R will be administered by a qualified rater at 
the site and the same study site rater should perform all CDRS-R assessments for a given subject 
whenever possible. 
Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S): The CGI-BP-S 
is a three-part clinician-rated assessment of the subject’s current illness state (depression, mania, 
and overall) using a 7-point scale for each part, where a higher score is associated with greater 
illness severity. Following a clinical interview, the CGI-BP-S can be completed in 1-2 minutes. 
The CGI-BP-S will be administered by a qualified rater at the site and the same study site rater 
should perform all CGI-BP-S assessments for a given subject whenever possible. 
Pediatric Anxiety Rating Scale (PARS):  The PARS is a clinician-rated instrument for 
assessing over time the severity of anxiety symptoms associated with common DSM-IV anxiety 
disorders (generalized anxiety disorder, separation anxiety, and social phobia) in children ages 
6-17 years. The PARS will be administered separately to the subject and to the caregiver. The 
instrument has 2 sections.  The first section includes a 50-item symptom checklist, which the 
clinician rates as present or absent during the past week. The second section is comprised of 7 
severity impairment items that are rated on a 6 point Likert scale. The 7 severity impairment 
items reflect the severity/impairment of all symptoms endorsed in Section 1 of the PARS (during 
the past week). The PARS will be administered by a qualified rater at the site and the same study 
site rater should perform all PARS assessments for a given subject whenever possible. 
Attention-Deficit/ Hyperactivity Disorder Rating Scale (ADHD-RS): The ADHD-RS IV was 
developed to measure the behaviors of children with ADHD. The ADHD-RS IV is a validated 
scale that consists of 18 items designed to reflect current symptomatology of ADHD based on 
DSM-IV-TR criteria. Each item is scored from a range of zero (reflecting no symptoms) to three 
(reflecting severe symptoms) with total scores ranging from zero to 54. The 18 items may be 
grouped into two sub-scales: hyperactivity/impulsivity (even number items 2 through 18) and 
inattentiveness (odd number items 1 through 17). The ADHD-RS will be administered to the 
caregiver by a qualified rater at the site and the same study site rater should perform all ADHD-
RS assessments for a given subject whenever possible. 
11.1.2. 
Safety 
Vital Signs: Vital signs following 5 minutes of seated rest will consist of supine systolic and 
diastolic blood pressures, respiration rate, heart rate, and oral body temperature.  
Blood pressure and heart rate should first be taken with the subject in the supine position after 
resting for ≥ 5 minutes. Blood pressure and heart rate will be taken again after standing for 2 to 
4 minutes. The same arm should be used during each assessment of blood pressure and heart rate 
throughout the study. If a subject develops symptoms consistent with orthostatic hypotension 
(light-headedness, dizziness, or changes in sensorium upon standing) at any point, his or her 
supine and standing blood pressure and heart rate should be collected at that time in the manner 
described above. Vital signs will be obtained prior to clinical laboratory collection and 
performance of an ECG.  

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Orthostatic effects: Orthostatic changes with clinically significant symptoms should be 
recorded as AEs. The categorization of orthostatic effects is intended for the data analysis and 
reporting of group effects and does not constitute guidance as to whether individual assessments 
reflect clinically meaningful changes. 
Physical Examination Assessments: A full physical examination will be performed. The 
physical examination includes an assessment of general appearance and a review of systems 
(dermatologic, head, eyes, ears, nose, mouth/throat/neck, thyroid, lymph nodes, respiratory, 
cardiovascular, gastrointestinal, extremities, musculoskeletal, neurologic, and psychiatric 
systems).  
Weight, height, and waist circumference: Weight and height should be measured in street 
clothing with no shoes. Waist circumference measurement should be taken around the body at 
the level of the abdomen and just above the hip bone. The waist circumference measurement is 
usually taken immediately after exhalation. 
Centrally-read ECG: All ECGs will be obtained in the supine position, after the subject has 
been resting supine for at least 10 minutes. ECGs will be 12-lead with a 10-second rhythm strip. 
ECGs should be obtained prior to drawing blood samples. All attempts should be made to use the 
same ECG recorder for all visits within individual subjects. ECGs will be centrally read at a core 
lab according to established quality assurance procedures for inter/intra reader variability.  
Clinical Laboratory: For detailed instructions regarding laboratory procedures, sampling, and 
shipping guidelines refer to the Central Laboratory Instructions Manual. Samples will be 
processed at a central laboratory to ensure consistency. All laboratories will be College of 
American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) (or 
equivalent) certified. See Appendix A for a list of required clinical laboratory tests. 
Hyperglycemia will be defined as any glucose result of ≥ 126 mg/dL; dyslipidemia will be 
defined as any result of total cholesterol ≥ 240 mg/dL or triglycerides ≥ 200 mg/dL. 
Adverse Events: As a discussion guide, subjects should be queried in a non-leading manner, 
without specific prompting (eg, “Has there been any change in your health status since your last 
visit?”). See Appendix C.  
Concomitant Medications and Medical History: Subject and caregiver self-report will be 
acceptable for listing all concomitant medication use, medical history, psychiatric history, and 
evaluation for inclusion/exclusion except where specific protocol procedures are mandated to 
ensure appropriate enrollment (eg, certain baseline lab values). 
Simpson-Angus Scale (SAS): The SAS is a clinician-rated assessment of neuroleptic-induced 
parkinsonism consisting of 10 items. Items are anchor-based, rated on a 5-point scale, and 
address rigidity, gait (bradykinesia), tremor, glabellar tap, and salivation (Simpson, 1970). SAS 
raters will be required to meet specific credential and educational criteria before they are 
certified to rate for this study. The same study site rater should perform all SAS assessments for 
a given subject whenever possible. 
Barnes Akathisia Rating Scale (BARS): The BARS (Barnes, 1989, Barnes, 2003, 
Schooler, 2000) is a rating scale geared toward assessment of neuroleptic-induced akathisia, 
though it can be used to measure akathisia associated with other drugs as well. The BARS 
consists of 4 items, including one item assessing objective restlessness, 2 items targeting 

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subjective restlessness (awareness and related distress), and one global clinical assessment item. 
All items are anchored and utilize a 4-point scale, except for the global rating which has a 6-
point scale (from absence of akathisia through severe akathisia). The subjective and objective 
items are summed to yield a total score. The BARS can be administered in about 10 minutes. 
The BARS will be administered by a qualified rater at the site. The same study site rater should 
perform all BARS assessments for a given subject whenever possible. 
Abnormal Involuntary Movement Scale (AIMS): The AIMS is a clinician-rated assessment of 
abnormal movements consisting of unobtrusive observation of the subject at rest (with shoes 
removed) and several questions or instructions directed toward the subject. Using a severity scale 
ranging from 0 (none) to 4 (severe), clinicians rate dyskinesia in several body regions, including 
the facial area, extremities, and trunk. There are 2 items related to dental status, as well as 
3 global impression items assessing overall severity, incapacitation, and the subject’s awareness 
of abnormal movements (Guy, 1976; Munetz, 1988). AIMS raters will be required to meet 
specific credential and educational criteria before they are certified to rate for this study. The 
same study site rater should perform all AIMS assessments for a given subject whenever 
possible. 
Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU): The Udvalg for Kliniske 
Undersøgelser (UKU) Side Effect Rating Scale (Lingiaerde, 1987) is a comprehensive, clinician-
rated scale, designed to assess the side effects in patients treated with psychotropic medications. 
The UKU contains information obtained via interviews with the patient, as well as observations 
made by the clinician. The UKU consists of 48 questions. A rating can typically be assessed 
within 30 minutes. Each point on the UKU is assigned a degree of zero, one, two or three. 
Zero indicates normal; one indicates mild symptoms; two indicates moderate symptoms; and 
three indicates severe symptoms. The same study site rater should perform all UKU assessments 
for a given subject whenever possible. 
Columbia Suicide Severity Rating Scale (C-SSRS): The C-SSRS is a tool designed to 
systematically assess and track suicidal adverse events (suicidal behavior and suicidal ideation) 
throughout the trial. The strength of this suicide classification system is in its ability to 
comprehensively identify suicidal events while limiting the over-identification of suicidal 
behavior. The scale takes approximately 5 minutes to administer. The C-SSRS will be 
administered by a trained rater at the site. Subjects with Type 4 (active suicidal ideation with 
some intent to act, without specific plan) or Type 5 (active suicidal ideation with specific plan 
and intent) suicidal ideation during the study will be discontinued from the study and referred to 
a mental health professional. The same study site rater should perform all C-SSRS assessments 
for a given subject whenever possible. 
Young Mania Rating Scale (YMRS): The YMRS is an 11-item instrument used to assess the 
severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated 
Mood, Increased Motor Activity Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and 
Amount), Language-Thought Disorder, Content, Disruptive-Aggressive Behaviour, Appearance 
and Insight. The YMRS is a clinician-rated assessment and uses operationally-defined anchor 
points. Ratings are based on patient self-reporting, combined with clinician observation 
(accorded greater score). The YMRS will be administered separately to the subject and to the 
caregiver by a qualified rater at the site and the same study site rater should perform all YMRS 
assessments for a given subject whenever possible. 

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CogState Computerized Cognitive Test Battery: The CogState Computerized Cognitive Test 
Battery is a computerized testing platform designed to provide brief, standardized, and easily 
administered assessment of a range of cognitive functions. The CogState test battery to be used 
in this study consists of four tasks each designed to specifically assess functioning in the 
following cognitive domains: psychomotor speed (detection task); attention (identification task); 
learning/memory (one card learning task); and working memory (one back task). The 
computerized test will be administered to each subject using the computer interface at the study 
site. 
Tanner Staging: a scale of physical development in children, adolescents and adults. The scale 
defines physical measurements of development based on external primary and secondary sex 
characteristics, such as the size of the breasts, genitalia, testicular volume and development of 
pubic and axillary hair. 
Menstrual cyclicity (female subjects only): Menstrual cyclicity will be monitored in female 
subjects who have begun menses. Female subjects will be given a calendar to mark the beginning 
and end of each menses. This calendar will be reviewed at each visit. 
11.2. 
Standardization of Data Capture 
Study Schematic and Schedule of Assessments: A schematic of the study design and summary 
of assessments to be conducted at each visit are presented in Figure 1 and Table 3, Table 4, and 
Table 5, respectively. 
Assessment Windows: Assessments will be conducted within the time frames specified 
(ie ± 3 days). All times are relative to the time of dosing for individual subjects 
11.3. 
Electronic Data Capture (EDC)  
The study sites will use a validated EDC system to enter subject data onto CRFs. Medidata 
RAVE will be used for this clinical study. Password protected access to the EDC system will be 
via a secure website. Data queries and data corrections will be handled through the same system. 
All transactions within the EDC system are fully documented within an electronic audit trail. 
Each set of completed CRFs must be reviewed and electronically signed and dated by the 
investigator.  
11.4. 
Study Visits and Assessments 
11.4.1. 
Visit 1E (Day 1) 
Visit 1E (Day 1) – this visit will occur on the same day as Study Visit Number 9 in 
Study D1050301 and Study D1050325 and Study Visit Number 8 in Study D1050326. 
Note:  Assessments specific to this study are listed below; all other assessments will be 
carried over from Study Visit Number 9 in Study D1050301 and Study D1050325 and 
Study Visit Number 8 in Study D1050326. 
• Obtain informed consent/assent 
• Inclusion/exclusion criteria 

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• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication  
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
11.4.2. 
Visit 2E (Week 2) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.3. 
Visit 3E (Week 4) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 

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• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.4. 
Visit 4E (Week 6) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Height as measured by stadiometer 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Weight  
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 

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• Children’s Global Assessment Scale (CGAS) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Positive and Negative Syndrome Scale (PANSS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Aberrant Behavior Checklist (ABC) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs) 
• Caregiver Strain Questionnaire (CGSQ) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Children’s Depression Rating Scale, Revised (CDRS-R) 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Young Mania Rating Scale (YMRS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Pediatric Anxiety Rating Scale (PARS) 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) 
11.4.5. 
Visit 5E (Week 8) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  

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• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.6. 
Visit 6E (Week 12) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Height as measured by stadiometer 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Weight  
• Waist circumference measurement 
• Hematology, chemistry, and urinalysis 
• Hormonal Parameters 
• Serum prolactin 
• Glycosylated hemoglobin (HbA1c) 
• Glucose and lipid panel 
• Serum insulin and C-reactive protein 
• Urine drug screen  

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• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Children’s Global Assessment Scale (CGAS) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Positive and Negative Syndrome Scale (PANSS) 
• CogState Cognitive Test Battery  
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Aberrant Behavior Checklist (ABC) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs) 
• Caregiver Strain Questionnaire (CGSQ) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Children’s Depression Rating Scale, Revised (CDRS-R) 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Children’s Global Assessment Scale (CGAS) 
• Young Mania Rating Scale (YMRS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Pediatric Anxiety Rating Scale (PARS) 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) 
• CogState Cognitive Test Battery  
11.4.7. 
Visit 7E (Week 16) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 

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• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.8. 
Visit 8E (Week 20) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 

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• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.9. 
Visit 9E (Week 24) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 

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• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.10. 
Visit 10E (Week 28) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Physical examination 
• Height as measured by stadiometer 
• Tanner staging 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Weight  
• Waist circumference measurement 
• Electrocardiogram (ECG) 
• Hematology, chemistry, and urinalysis 
• Hormonal Parameters 
• Serum prolactin 
• Glycosylated hemoglobin (HbA1c) 
• Glucose and lipid panel 
• Serum insulin and C-reactive protein 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children’s Global Assessment Scale (CGAS) 

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• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Positive and Negative Syndrome Scale (PANSS) 
• CogState Cognitive Test Battery 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Aberrant Behavior Checklist (ABC) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs) 
• Caregiver Strain Questionnaire (CGSQ) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Children’s Depression Rating Scale, Revised (CDRS-R) 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Children’s Global Assessment Scale (CGAS) 
• Young Mania Rating Scale (YMRS) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Pediatric Anxiety Rating Scale (PARS) 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) 
• CogState Cognitive Test Battery  
11.4.11. 
Visit 11E (Week 32) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 

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• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.12. 
Visit 12E (Week 36) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 

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• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.13. 
Visit 13E (Week 40) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Physical examination 
• Height as measured by stadiometer 
• Tanner staging 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Weight  
• Waist circumference measurement 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children’s Global Assessment Scale (CGAS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Positive and Negative Syndrome Scale (PANSS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 

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• Aberrant Behavior Checklist (ABC) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs) 
• Caregiver Strain Questionnaire (CGSQ) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Children’s Depression Rating Scale, Revised (CDRS-R) 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Children’s Global Assessment Scale (CGAS) 
• Young Mania Rating Scale (YMRS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Pediatric Anxiety Rating Scale (PARS) 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) 
11.4.14. 
Visit 14E (Week 44) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
59 
30 Jun 2017 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.15. 
Visit 15E (Week 48) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.16. 
Visit 16E (Week 52) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
60 
30 Jun 2017 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Physical examination 
• Height as measured by stadiometer 
• Tanner staging 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Weight  
• Waist circumference measurement 
• Electrocardiogram (ECG) 
• Hematology, chemistry, and urinalysis 
• Hormonal Parameters 
• Serum prolactin 
• Glycosylated hemoglobin (HbA1c) 
• Glucose and lipid panel 
• Serum insulin and C-reactive protein 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children’s Global Assessment Scale (CGAS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Positive and Negative Syndrome Scale (PANSS) 
• CogState Cognitive Test Battery 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
61 
30 Jun 2017 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Aberrant Behavior Checklist (ABC) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs) 
• Caregiver Strain Questionnaire (CGSQ) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Children’s Depression Rating Scale, Revised (CDRS-R) 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Children’s Global Assessment Scale (CGAS) 
• Young Mania Rating Scale (YMRS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Pediatric Anxiety Rating Scale (PARS) 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) 
• CogState Computerized Cognitive Test Battery 
11.4.17. 
Visit 17E (Week 56) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
62 
30 Jun 2017 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.18. 
Visit 18E (Week 60) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
63 
30 Jun 2017 
11.4.19. 
Visit 19E (Week 64) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Height as measured by stadiometer 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Weight  
• Waist circumference measurement 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children’s Global Assessment Scale (CGAS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Positive and Negative Syndrome Scale (PANSS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Aberrant Behavior Checklist (ABC) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs) 
• Caregiver Strain Questionnaire (CGSQ) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Children’s Depression Rating Scale, Revised (CDRS-R) 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
64 
30 Jun 2017 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Children’s Global Assessment Scale (CGAS) 
• Young Mania Rating Scale (YMRS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Pediatric Anxiety Rating Scale (PARS) 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) 
11.4.20. 
Visit 20E (Week 68) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
65 
30 Jun 2017 
11.4.21. 
Visit 21E (Week 72) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.22. 
Visit 22E (Week 76) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Physical examination 
• Height as measured by stadiometer 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
66 
30 Jun 2017 
• Tanner staging 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Weight  
• Waist circumference measurement 
• Electrocardiogram (ECG) 
• Hematology, chemistry, and urinalysis 
• Hormonal Parameters 
• Serum prolactin 
• Glycosylated hemoglobin (HbA1c) 
• Glucose and lipid panel 
• Serum insulin and C-reactive protein 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children’s Global Assessment Scale (CGAS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Positive and Negative Syndrome Scale (PANSS) 
• CogState Cognitive Test Battery 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Aberrant Behavior Checklist (ABC) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs) 
• Caregiver Strain Questionnaire (CGSQ) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
67 
30 Jun 2017 
• Children’s Depression Rating Scale, Revised (CDRS-R) 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Children’s Global Assessment Scale (CGAS) 
• Young Mania Rating Scale (YMRS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Pediatric Anxiety Rating Scale (PARS) 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) 
• CogState Computerized Cognitive Test Battery 
11.4.23. 
Visit 23E (Week 80) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
68 
30 Jun 2017 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.24. 
Visit 24E (Week 84) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.25. 
Visit 25E (Week 88) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Height as measured by stadiometer 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
69 
30 Jun 2017 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Weight  
• Waist circumference measurement 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children’s Global Assessment Scale (CGAS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Positive and Negative Syndrome Scale (PANSS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Aberrant Behavior Checklist (ABC) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs) 
• Caregiver Strain Questionnaire (CGSQ) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Children’s Depression Rating Scale, Revised (CDRS-R) 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Children’s Global Assessment Scale (CGAS) 
• Young Mania Rating Scale (YMRS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Pediatric Anxiety Rating Scale (PARS) 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
70 
30 Jun 2017 
11.4.26. 
Visit 26E (Week 92) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.27. 
Visit 27E (Week 96) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
71 
30 Jun 2017 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.28. 
Visit 28E (Week 100) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Dispense study medication 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
72 
30 Jun 2017 
• Clinical Global Impression – Severity Scale (CGI-S) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
11.4.29. 
Visit 29E EOS/ET (Week 104) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
• Study drug accountability/assess compliance 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Physical examination 
• Height as measured by stadiometer 
• Tanner staging 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Weight  
• Waist circumference measurement 
• Electrocardiogram (ECG) 
• Hematology, chemistry, and urinalysis 
• Hormonal Parameters 
• Serum prolactin 
• Glycosylated hemoglobin (HbA1c) 
• Glucose and lipid panel 
• Serum insulin and C-reactive protein 
• Urine drug screen  
• Urine β-hCG (female subjects ≥ 11 years of age only) 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Clinical Global Impression – Severity Scale (CGI-S) 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
73 
30 Jun 2017 
• Children’s Global Assessment Scale (CGAS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Positive and Negative Syndrome Scale (PANSS) 
• CogState Cognitive Test Battery 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
• Aberrant Behavior Checklist (ABC) 
• Clinical Global Impression – Severity Scale (CGI-S) 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs) 
• Caregiver Strain Questionnaire (CGSQ) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Children’s Depression Rating Scale, Revised (CDRS-R) 
• Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
• Children’s Global Assessment Scale (CGAS) 
• Young Mania Rating Scale (YMRS) 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
• Pediatric Anxiety Rating Scale (PARS) 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) 
• CogState Computerized Cognitive Test Battery 
11.4.30. 
Visit 30E (Week 105) 
• Interactive Voice/Web Response System (IXRS) subject registry/visit 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
• Prior/concomitant medication review 
• Adverse event (AE) monitoring 
• Menstrual cyclicity (female subjects) 
• Vital signs 
• Urine β-hCG (female subjects ≥ 11 years of age only) 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
74 
30 Jun 2017 
• Simpson-Angus Scale (SAS) 
• Barnes Akathisia Rating Scale (BARS) 
• Abnormal Involuntary Movement Scale (AIMS) 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
Clinical Evaluations: SUBJECTS from D1050326 ONLY 
• Columbia Suicide Severity Rating Scale (C-SSRS) 
 
 
 

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
75 
30 Jun 2017 
12. 
DISCONTINUATION AND REPLACEMENT OF SUBJECTS/ 
CLINICAL ASSESSMENTS AFTER STUDY MEDICATION 
DISCONTINUATION  
Subjects may withdraw from the study at any time for any reason. 
12.1. 
Study Participation Termination Criteria 
The reason for early discontinuation from study participation is to be recorded as one of the 
following: 
• Adverse event (specify) 
• Lack of efficacy (specify) 
• Lost to follow-up (specify) 
• Other (specify) 
• Protocol violation (specify) 
• Withdrawal by subject (specify) 
Discontinuations due to an adverse event may include laboratory, vital signs, or other test 
abnormalities that result in early discontinuation. Please note that all AEs are to be recorded on 
the AE page. Serious adverse events that result in discontinuation or that result in death (an 
outcome resulting from an AE) are to be recorded on the AE page. The investigator or study 
coordinator must notify the Sponsor or Sponsor designee as soon as possible when a subject has 
been discontinued/withdrawn due to an AE (telephone or fax). 
Subjects whose study participation is prematurely terminated will not be replaced.  
12.2. 
Follow-up Procedures Upon Discontinuation/Withdrawal 
If a subject discontinues study medication treatment due to an AE, then the subject should be 
evaluated until resolution or stabilization of the adverse event. When a subject 
discontinues/withdraws prior to study completion, all applicable activities scheduled for the final 
study visit should be performed at the time of discontinuation. A termination eCRF page should 
be completed for every subject who received study medication whether or not the subject 
completed the study. The reason for discontinuation should be indicated on the eCRF. Any AEs 
that are present at the time of discontinuation/withdrawal should be followed in accordance with 
the safety requirements outlined in Section 13. Subjects who discontinue from the study will not 
be replaced. Subjects who discontinue from the study must be referred by the Investigator for 
appropriate follow-up care. 
For all subjects a follow-up visit will be scheduled for 7 (± 3) days after the last dose of study 
medication to monitor AEs and SAEs. If an in-person visit is not possible, telephone contact will 
be made with the subject to assess any post study discontinuation adverse effects.  

Protocol D1050302 Version 4.0 
 
Lurasidone 
 
Confidential and Proprietary 
76 
30 Jun 2017 
13. 
ADVERSE EXPERIENCE REPORTING 
13.1. 
Adverse Events  
An adverse event (AE) is any new, untoward medical occurrence or worsening of a pre-existing 
medical condition that occurs during study participation, whether or not the event is considered 
drug related.  
AEs will be collected from the time the informed consent is signed to the end of the study. 
Serious adverse events (SAEs) will be collected and reported on the SAE form, from the time of 
informed consent to 14 days post last dose and will be followed until resolution or lost to follow 
up. SAEs occurring from the time of informed consent to the end of study must be recorded on 
the CRF and the data recorded should match that on the SAE form. 
Non-leading questions will be used to ask subjects about the possible occurrence of AEs. The 
investigator should attempt to establish a diagnosis of the event based on signs, symptoms, 
and/or other clinical information. In such cases, the diagnosis should be documented as the AE 
and not the individual signs/symptoms. 
Following questioning and evaluation, all AEs, whether believed by the investigator to be related 
or unrelated to the study medication, must be documented in the subject’s study records/source 
documents, in accordance with the investigator’s normal clinical practice, and on the AE page of 
the CRF. Each AE is to be evaluated for duration, intensity, seriousness, and causal relationship 
to the study medication. Appendix C (Definitions for Reporting Adverse Events) provides 
definitions for severity of an adverse event, relationship to study medication, frequency, and 
action taken. An AE is deemed associated with the use of the study drug “if there is a reasonable 
possibility that the experience may have been caused by the drug” (21 CFR 312.32 [a]).  
The Medical Monitor is the initial contact person for protocol related questions or discussion of 
AEs. The contact information for the Medical Monitor as well as other emergency contact 
information can be found in Table 1 of this protocol. 
13.2. 
Objective Findings 
New and worsening signs and symptoms of underlying or emerging disease must be recorded as 
AEs. Clinically significant abnormal objective findings (eg, clinical laboratory value, ECG 
value, and physical examination observation) will also be recorded on the Adverse Event page of 
the CRF from signing of the informed consent onwards. When a clear diagnosis is available that 
explains the objective findings, this diagnosis will be recorded as the AE, and not the abnormal 
objective finding (eg, viral hepatitis will be recorded as the AE, not transaminase elevation). If a 
definite diagnosis is not available, then record the sign (eg, clinically significant elevation of 
transaminase levels) or symptom (eg, abdominal pain) as the AE. 
Clinical laboratory test results will be reviewed by an investigator as they become available. The 
investigator must determine the clinical significance of all out of range values. Possibly 
drug-related or clinically relevant abnormal values of uncertain causality must be repeated. Any 
abnormal values that persist should be followed at the discretion of the investigator. Laboratory 
reports will be initialed and dated on all pages by a Form FDA 1572-listed investigator. 

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All on site ECG tracings and ECG over-read reports will be reviewed by an investigator as they 
become available. The investigator must determine the clinical significance of all abnormal ECG 
interpretations on the machine read tracing. Possibly drug-related or clinically relevant abnormal 
ECGs of uncertain causality must be repeated. Any abnormal ECGs that persist should be 
followed at the discretion of the investigator. ECG tracings will be initialed and dated on all 
pages by a Form FDA 1572-listed investigator. 
13.3. 
Immediately Reportable Events 
There are two categories of medical events that could occur during participation in a clinical 
study that must be immediately reported:  
• SAE, including death. 
• The incidence of pregnancy.  
The appropriate Pharmacovigilance (PVG) group must be contacted immediately upon first 
knowledge of the incident. 
Emergency contact information can be found in Table 1 of this protocol. 
An AE or suspected adverse reaction is considered “serious” if, in the view of either the 
investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening AE, 
in-patient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital 
anomaly/birth defect. Important medical events that may not result in death, be life-threatening, 
or require hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition.  
Life-threatening means that the subject was, in the view of the investigator, at immediate risk of 
death from the event as it occurred. This definition does not include an event that, had it occurred 
in a more severe form might have caused death. 
If an investigator or study site staff becomes aware of a SAE that occurs in a study subject from 
the time that informed consent is signed through 14 days following the last dose of study 
medication, this must be reported immediately to PVG. 
In addition to the initial telephone notification, an initial SAE form as applicable must be 
completed and sent via fax to PVG within 1 business day of an investigator or study site staff 
becoming aware of the event. Sunovion Pharmaceuticals Inc. provides the SAE form used to 
report SAEs as a part of the document package necessary to conduct this clinical study.  
Sunovion Pharmaceuticals Inc. will promptly notify all research sites of an AE that is determined 
to be reportable to the Regulatory Authorities. These AEs must be promptly reported to the 
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) by the Principal 
investigator. 
If a subject becomes pregnant during the course of the study, she will be instructed to 
immediately stop taking study medication. Further, the subject will be instructed to return within 
48 hours of the first notification of pregnancy to the research site and undergo a serum pregnancy 
test, as confirmation of pregnancy. If positive, the subject will no longer receive any additional 

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study medication and will continue to be followed. All pregnancies, whether or not the subject 
received any study medication, will be followed until resolution (ie, termination [voluntary or 
spontaneous] or birth).  
If a pregnancy is reported for the study subject’s partner, the Sponsor’s representative will 
provide instructions on how to collect pregnancy information in accordance with local 
requirements. Proper consent to collect the partner’s information will be obtained prior to the 
collection of any information. 
To report a pregnancy, the Pregnancy Event Form must be completed and sent via facsimile to 
PVG within 1 business day of first knowledge by the research personnel of the pregnancy. 
Sunovion Pharmaceuticals Inc. provides the Pregnancy Event Form as a part of the document 
package necessary to conduct this clinical study. Pregnancies occurring from the time the 
informed consent is signed through 7 days following the last dose of study medication, will be 
followed quarterly until birth or termination of the pregnancy.  
13.3.1. 
Bone Fractures 
All confirmed cases of bone fracture, regardless of seriousness or presumed relationship to study 
drug, must be reported as SAEs. All procedures for reporting of SAEs as detailed in the current 
protocol are to be followed for these events. 
13.4. 
Preplanned Hospitalizations or Procedures 
During the study, if a subject has a hospitalization or procedure (eg, elective surgery) that was 
scheduled prior to the subject entering the study (ie, before the subject signed the informed 
consent form [ICF]) for an event/condition that occurred before the study, the hospitalization is 
considered a therapeutic intervention and not the result of an SAE. It should have been clearly 
documented prior to signing the ICF. However, if the event/condition worsens during the study, 
it must be reported as an AE (or SAE, if the event/condition results in a serious outcome such as 
prolongation of hospitalization). 
13.5. 
Data and Safety Monitoring Board 
A DSMB will review safety and clinical outcome data including data on AEs and SAEs at 
regular intervals until the D1050301, D1050325, and D1050326 studies are complete and as long 
as necessary for the D1050302 study, as determined by the Sponsor. The DSMB will be 
independent of the Sponsor, CRO, and the investigators and will be empowered to recommend 
stopping the study due to safety concerns, but not for efficacy or futility. The membership of the 
DSMB and its mandate is denoted in the DSMB charter. 
 
 
 

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14. 
STATISTICS 
A Statistical Analysis Plan (SAP) will provide details on the statistical methods planned for this 
study and will be finalized prior to the 1st interim data cut, which will happen when at least 
100 subjects continued from studies D1050301 and D1050325 complete the Week 28 Visit. 
14.1. 
Randomization and Blinding 
This is an open-label study, therefore randomization and blinding will not be employed. 
14.2. 
Unblinding Procedures 
This section is not applicable to this study. 
14.3. 
Hypotheses 
Because of the nature of an open-labeled study, no hypotheses are planned. 
14.4. 
Variables and Timepoints 
14.4.1. 
Primary Safety Variables 
The primary safety variables include treatment-emergent AEs and SAEs, and discontinuations 
due to AEs. 
14.4.2. 
Other Safety Variables 
Safety and tolerability will further be assessed by the following variables: laboratory values, 
ECGs, physical examinations, movement disorders (AIMS, BARS, and SAS scores), vital signs, 
height, weight, BMI, waist circumference, tanner staging, menstrual cyclicity (female subjects), 
and hormonal parameters. For subjects previously enrolled in the D1050301 and D1050326, 
safety will further be assessed by CogState Cognitive Test Battery, C-SSRS, and UKU. In 
addition, for subjects previously enrolled in study D1050326, Young Mania Rating Scale 
(YMRS) will be also assessed. 
14.5. 
Sample Size Considerations 
Subjects who complete the respective double-blind studies D1050301, D1050325 or D1050326, 
sign the consent, and meet all entry criteria will be included in this study. Studies D1050301, 
D1050325, and D1050326 have finished, with a total of 271 subjects from D1050301, 
125 subjects from D1050325, and 306 subjects from D1050326 enrolling into D1050302. Based 
on an estimated attrition rate of approximately 30% of subjects over six months, it is expected 
that at least 100 subjects will be exposed to lurasidone for a minimum of 6 months for subjects 
continued from Studies D1050301 and D1050325 in Study D1050302. 
14.6. 
Data Analyses of Interim Data for FDA Filing 
After studies D1050301 and D1050325 are completed, when at least 100 subjects complete the 
Week 28 visit (ie, exposed to study drug for at least 6 months), data analyses based on these 

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interim data will be done to prepare a safety/effectiveness report in support of the initial health 
authority filing for US regulatory submission for the lurasidone pediatric program. A subsequent 
final analysis of study D1050302 will be performed after every subject previously enrolled from 
study D1050301, D1050325, and D1050326 complete the study. The details of the interim data 
analyses and final data analyses are provided below in Section 14.7, and the SAP. 
14.7. 
Data Analyses 
All data collected in this 104 week open-label study will be summarized and presented in final 
data analyses report. All data collected through the cut-off time point when at least 100 subjects 
previously from studies D1050301 and D1050325 complete the Week 28 Visit will be 
summarized separately for a study report for FDA filing. 
Continuous variables will be summarized using descriptive statistics (number of subjects, mean, 
median, standard deviation or standard error, minimum and maximum values, and 
95% confidence interval) by visit. Categorical variables will be reported as frequencies and 
percentages by visit. Standard laboratory shift tables will be reported. Where changes are 
reported, the reference will be to the pre-treatment baseline from double-blind studies D1050301, 
D1050325, or D1050326, as indicated as “DB baseline”. Where relevant, changes from baseline 
for the open-label study, as defined as the Week 6 assessment in the double-blind study or the 
last assessment prior to the first dose of the open label study, will also be reported, and will be 
referred to as the open-label study baseline or "OL baseline." 
14.7.1. 
Analysis Population 
Safety population: 
The safety population will consist of all subjects who receive at least one dose of study 
medication. 
14.7.2. 
Definitions of Assessments 
The following definitions will be used for efficacy assessments: 
• DB Baseline (ie, Baseline assessment of the double-blind studies [D1050301, 
D1050325, or D1050326]): the last assessment made on or before double-blind 
randomization as described in the protocols; 
• OL Baseline (ie, Endpoint assessment of the double-blind studies [D1050301, 
D1050325, or D1050326]) or Baseline assessment of the open-label study 
(D1050302): the last assessment made during the double-blind studies, as described 
in the protocols; 
• Week 28 Endpoint assessment: the last post-baseline assessment made prior to or at 
Week 28 visit. 
• Week 104 Endpoint assessment: the last post-baseline assessment made during the 
open-label study (D1050302), as described in the protocol; 
• Scheduled assessment: assessment made during the open-label study (D1050302). 

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14.7.3. 
Analysis Group 
A total of three analysis groups will be formed based on a subject’s previous participation in  
double-blind studies D1050301, D1050325, and D1050326: 
• All subjects previously enrolled in Study D1050301 and enrolled into this extension 
study. 
• All subjects previously enrolled in Study D1050325 and enrolled into this extension 
study. 
• All subjects previously enrolled in Study D1050326 and enrolled into this extension 
study. 
Summary tables, wherever applicable, will be presented for all subjects in the study by above 
analysis group, respectively. 
14.7.4. 
Statistical Methods 
Unless otherwise specified, analysis outputs will be presented for subjects who complete 
double-blind studies D1050301, D1050325, or D1050326, respectively and analyses presented 
will be based on the safety population. 
14.7.4.1. Efficacy Evaluation 
All efficacy evaluations will be summarized for all subjects and by analysis group listed 
Section 14.7.3. 
The efficacy variables to be summarized for this study will include: 
For subjects continued from Study D1050301: 
• Positive and Negative Syndrome Scale (PANSS) total, positive, negative, general 
psychopathology, cognition, and excitability subscale scores; 
• Clinical Global Impression severity (CGI-S) scale; 
• Clinician-rated Children’s Global Assessment Scale (CGAS); 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q). 
For subjects continued from Study D1050325: 
• Aberrant Behavior Checklist (ABC) subscale scores (irritability, hyperactivity, 
stereotypy, inappropriate speech, and lethargy/social withdrawal); 
• Clinical Global Impression severity (CGI-S) scale; 
• Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs); 
• Caregiver Strain Questionnaire (CGSQ). 
For subjects continued from Study D1050326: 
• Children's Depression Rating Scale, Revised (CDRS-R); 
• Clinical Global Impression Bipolar Version -Severity (CGI-BP-S) scale; 

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• Clinician-rated Children’s Global Assessment Scale (CGAS); 
• Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q); 
• Pediatric Anxiety Rating Scale (PARS); 
• Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS). 
Since this is an uncontrolled open-label extension of studies D1050301, D1050325, and 
D1050326, no inferential statistics on efficacy will be presented. For all of the efficacy 
assessments, summary statistics (number of subjects, mean, standard deviation, minimum, 
median, and maximum and a 95% confidence interval) will be presented for all subjects by 
analysis group for the DB baseline, OL baseline, each of the scheduled assessments, and the 
endpoint assessments in the open-label study. All analyses for the scheduled assessments will be 
based on observed cases (OC). Confidence intervals will be based on means and standard 
deviations estimated without adjustment for any center or baseline effects. In addition, for all 
efficacy evaluations, differences from DB baseline and OL baseline will be presented in a similar 
way using summary statistics, as described above. 
For time to early discontinuation, Kaplan-Meier curves will be plotted by analysis group. 
14.7.4.2. Safety Evaluation 
All safety evaluations will be summarized for all subjects by analysis group for the safety 
population. 
Safety evaluations include: 
• AEs, SAEs, Discontinuation due to AEs and SAEs; 
• Laboratory safety tests (chemistry, including liver function tests and bilirubin; 
hematology including HbA1c; serum lipids; glucose; hormonal parameters; and 
urinalysis); 
• Body weight, height, BMI, waist circumference, vital signs, physical examinations, 
and ECG parameters; 
• Simpson-Angus Scale (SAS); 
• Barnes Akathisia Rating Scale (BARS); 
• Abnormal Involuntary Movement Scale (AIMS); 
• Tanner staging, and menstrual cyclicity (female subjects). 
For subjects continued from Study D1050301 and D1050326: 
• Columbia Suicide Severity Rating Scale (C-SSRS); 
• CogState Cognitive Test Battery; 
• Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU). 
For subjects continued from Study D1050326: 
• Young Mania Rating Scale (YMRS) score. 

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The primary analysis for the study is to assess the incidence of AEs, SAEs, and discontinuations 
due to AEs. The terms used in the eCRFs by investigators to identify adverse events will be 
coded using the Medical Dictionary for Regulatory Activities (MedDRA). All reported adverse 
events with onset on or after the first dose of study drug during the treatment phase 
(ie, treatment-emergent adverse events) will be included in the analysis.  
AEs will be summarized by presenting the number and percentage of subjects having any AE, 
having an AE by body system, and having each individual AE. The incidence of an AE is 
determined by occurrence of at least one AE regardless of the frequency, severity and/or 
relationship to study medications. AEs will also be summarized by maximum severity and 
relationship to study medication (as assessed by the investigator), and action taken. 
Special attention will be given to those subjects who discontinue treatment due to an adverse 
event, or who experienced a severe or a serious adverse event (eg, summaries, listings, and 
narrative preparation may be provided, as appropriate). 
Descriptive statistics will be provided for the all other safety variables or tests and the 
corresponding changes from baseline (including double-blind study baseline and open-label 
study baseline) by scheduled visit. Notable values will be flagged, and any other information 
collected will be listed as appropriate. Continuous variables will be summarized using 
descriptive statistics (number of subjects, mean, standard deviation, median, minimum and 
maximum values). Categorical variables will be reported as frequencies and percentages. For 
weight, height, and BMI, descriptive statistics will be also summarized for the age-adjusted 
standardized scores. 
For subjects continued from study D1050301 and D1050326, descriptive statistics will be 
provided for Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) and the 
age-adjusted standardized CogState composite score. For C-SSRS, number and percentage of 
subjects with suicidal ideations and behaviors will be summarized.  
For subjects continued from study D1050326, descriptive statistics will be presented for YMRS 
result by analysis group and study visit. 
Frequency distribution of the tanner staging will be tabulated by visit and gender. 

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15. 
COMPUTERIZED SYSTEMS USED FOR SOURCE DATA 
A list of the computerized systems that will be used at each step to create, modify, maintain, 
archive, retrieve, or transmit source data are presented below, per the Guidance for Industry 
Computerized Systems Used in Clinical Investigations, May 2007. 
Table 8: 
Computerized Systems Used for Source Data 
Protocol Step  
Computerized System 
Type or Description 
Obtain informed consent/assent 
NA 
Inclusion/exclusion criteria 
A 
Prior/concomitant medication review 
A 
Interactive Voice/Web Response System (IXRS) subject registry/study medication 
assignment 
G 
Study drug accountability/assess compliance 
A 
Clinical and Laboratory Evaluations: ALL SUBJECTS 
 
Physical examination 
A 
Height as measured by stadiometer 
A 
Tanner staging 
A 
Vital signs 
A 
Weight  
A 
Waist circumference measurement 
A 
Electrocardiogram (ECG) 
C 
Hematology, chemistry, and urinalysis 
B 
Hormonal Parameters 
B 
Serum prolactin 
B 
Glycosylated hemoglobin (HbA1c) 
B 
Glucose and lipid panel 
B 
Serum insulin and C-reactive protein 
B 
Urine β-hCG 
NA 
Adverse event (AE) monitoring 
A 
Barnes Akathisia Rating Scale (BARS) 
A 
Abnormal Involuntary Movement Scale (AIMS) 
A 
Simpson-Angus Scale (SAS) 
A 
Clinical Evaluations: SUBJECTS from D1050301 ONLY 
 
Children’s Global Assessment Scale (CGAS) 
A 
Clinical Global Impression – Severity Scale (CGI-S) 
A 
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
A 
Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
A 

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Protocol Step  
Computerized System 
Type or Description 
Columbia Suicide Severity Rating Scale (C-SSRS) 
A 
Positive and Negative Syndrome Scale (PANSS) 
A 
CogState Cognitive Test Battery 
E 
Clinical Evaluations: SUBJECTS from D1050325 ONLY 
 
Aberrant Behavior Checklist (ABC) 
A 
Clinical Global Impression – Severity Scale (CGI-S) 
A 
Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for 
pervasive developmental disorders (PDDs) 
A 
Caregiver Strain Questionnaire (CGSQ) 
A 
Clinical Evaluations:  
SUBJECTS from D1050326 ONLY 
 
Children’s Depression Rating Scale, Revised (CDRS-R) 
A 
Clinical Global Impression-Bipolar Version, Severity of Illness (CGI BP-S) 
A 
Children’s Global Assessment Scale (CGAS) 
A 
Young Mania Rating Scale (YMRS) 
A 
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) 
A 
Columbia Suicide Severity Rating Scale (C-SSRS) 
A 
Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) 
A 
Pediatric Anxiety Rating Scale (PARS) 
A 
Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) 
A 
CogState Computerized Cognitive Test Battery 
E 
A = EDC (Medidata RAVE); B = LIMS; C = Core Lab Over-read; D = LIMS/ASCII; E = Computerized Assessment System; 
F = ePRO; G = IXRS.  
 Abbreviations: EDC = electronic data capture; CDR = clinical data repository; ePRO = electronic patient reported outcomes; 
IXRS = Interactive Voice/Web Response System; LIMS = laboratory information management system. 
 

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16. 
ETHICAL AND REGULATORY OBLIGATIONS 
16.1. 
Study Conduct 
The investigator agrees that the study will be conducted according to the protocol, the US Code 
of Federal Regulations (CFR), Good Clinical Practice (GCP) (E6) and the ethical principles that 
have their origin in the Declaration of Helsinki and the International Conference on 
Harmonisation (ICH) guidelines. The investigator will conduct all aspects of this study in 
accordance with all national, state, and local laws of the pertinent regulatory authorities. 
The investigator will assure proper implementation and conduct of the study including those 
study-related duties delegated to other appropriately qualified individuals. The investigator will 
assure that study staff cooperate with monitoring and current audits, and will demonstrate due 
diligence in recruiting and screening study subjects. 
The investigator must sign and return to CRO/Sponsor the "Study Acknowledgment" page and 
provide a copy of current curriculum vitae (CV), including a copy of a current medical license, 
current Drug Enforcement Agency (DEA) license, where applicable, and financial disclosure. In 
countries where medical licensure is not issued, the following documentation is acceptable, as 
applicable:  
• Registration number/stamp with a registration number stated on CV. 
• Appropriate diploma number stated on CV. 
• Copy of the diploma. 
For all studies conducted under an Investigational New Drug (IND), the investigator must sign 
and return a completed Form FDA 1572 "Statement of investigator" to CRO/Sponsor. 
16.2. 
Institutional Review Board or Independent Ethics Committee 
Before initiation of the study, the investigator/CRO must obtain approval or favorable opinion of 
the research protocol, informed consent form, and any advertisement for subject recruitment, 
from an IRB or IEC complying with the provisions specified in 21 CFR Part 56 or in ICH GCP, 
as applicable, and applicable pertinent government regulations. The investigator must assure IRB 
or IEC compliance with the applicable regulations. 
A copy of written IRB or IEC approval or favorable opinion of the protocol, informed consent 
form and advertising (if applicable) must be provided to CRO/Sponsor prior to initiation of the 
study. The approval or favorable opinion letter must be signed by the IRB or IEC chairman or 
designee, identify the IRB/IEC name and address, identify the clinical protocol by title and/or 
protocol number, and include the date that approval or favorable opinion was granted. The letter 
must also contain a statement that the IRB or IEC complies with the requirements in 21 CFR 
Part 56 for a study conducted under an IND or ICH GCP, as applicable. 
The investigator/CRO is responsible for obtaining continued review of the clinical research or 
submitting periodic progress reports, in accordance with applicable regulations, at intervals not 

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exceeding one year or otherwise specified by the IRB or IEC. The Sponsor must be supplied 
with written documentation of continued review of the clinical research. 
The investigator must promptly inform their IRB/IEC of all SAEs or other safety information 
reported from CRO/Sponsor in accordance with 21 CFR 312.66, or when dictated by applicable 
local regulations (ie, Directive 2001/20/EC), the Sponsor/CRO is responsible for reporting to the 
IEC (eg, reporting of serious AEs). 
16.3. 
Informed Consent 
The investigator will prepare the informed consent form and provide the form to CRO/Sponsor 
for approval prior to submission to the IRB or IEC. CRO/Sponsor may provide a template 
informed consent form to be qualified by each research facility to conform to local requirements. 
All informed consent forms must contain the minimum elements as mandated by the FDA or 
governing regulatory authority and ICH guidelines and will be subject to CRO/Sponsor approval 
as well as IRB or IEC approval. CRO/Sponsor may submit informed consent forms to a central 
IRB or IEC for review and approval or favorable opinion contingent upon prior investigator 
permission and review.  
Before recruitment and enrollment, where developmentally appropriate, each prospective 
candidate will be given a full explanation of the study, allowed to read the approved informed 
consent form or assent form for prospective candidates < 18 years of age and be provided ample 
time and the opportunity to ask any questions that may arise. Once all questions have been 
answered and the investigator is assured that the individual or parent or legal guardian for 
individuals < 18 years of age understands the implications of participating in the study, the 
subject will be asked to give consent or assent for subjects < 18 years of age to participate in the 
study by signing the informed consent/assent form. As part of the consent process, each subject 
must consent to direct access to his/her medical records for study-related monitoring, auditing, 
IRB/IEC review and regulatory inspection. The investigator will provide a copy of the signed 
informed consent form to each subject. For subjects < 18 years, the parent or legal guardian will 
be required to provide written informed consent. For subjects who become 18 years of age 
during the course of this study, they will need to give informed consent upon becoming 18 years 
of age (or as soon as possible thereafter). 
For this study, the parents or guardians must give permission for their children to participate and 
demonstrate their agreement by signing the informed consent document. The child or teenager 
will be provided with a form that explains, in age-appropriate terms, the purpose of the research, 
what they will be asked to do, and what procedures they will undergo. For this study, where 
developmentally appropriate, the assent of the child/or adolescent is deemed required. The assent 
process is an ongoing, interactive conversation between the research team and the child or young 
adult. If at any time the child or young adult shows signs of dissent, the assessment should be 
stopped, the situation assessed and assent established to continue. It should always be made clear 
that the young person has the right to leave the trial, at any time and for any reason, without 
penalty or consequences, and that any information gathered will be kept confidential. 
If an amendment to the protocol changes the subject participation schedule in scope or activity, 
or increases the potential risk to the subject, the informed consent form must be revised, 
submitted to the IRB or IEC for review and approval or favorable opinion. The revised informed 
consent form must be used to obtain consent from a subject currently enrolled in the study if he 

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or she is affected by the amendment. The revised informed consent form must be used to obtain 
consent from any new subjects who are enrolled into the study after the date of the approval or 
favorable opinion of the amendment. 
16.4. 
Subject Privacy 
The Sponsor’s staff or any designees affirm and uphold the subject’s confidentiality. Throughout 
this study, all data forward to the Sponsor will be identified only by an identification number, 
date of birth, gender, and initials. The investigator agrees that its representatives, its designee, 
representatives of the relevant IRB/IEC or representatives of the regulatory authorities will be 
allowed to review that portion of the subject’s primary medical records that directly concerns this 
study (including, but not limited to, clinical laboratory test result reports, ECG reports, 
admission/discharge summaries for hospital admissions occurring during a subject’s study 
participation and autopsy reports for deaths occurring during the study). 
For the studies conducted in the US, in accordance with the Healthcare Insurance, Portability, 
and Accountability Act of 1996, the investigator will prepare a privacy authorization form and 
provide the form to CRO/Sponsor for approval prior to submission to the IRB/IEC or to a 
Privacy Board. CRO/Sponsor may provide a template privacy authorization form to be qualified 
by each research facility to conform to local requirements. The content of the privacy 
authorization form must comply with the regulations governing the authorization. All 
prospective study candidates will be given full explanation of the privacy authorization form, 
allowed to read the approved form, and be provided the opportunity to ask any questions. Once 
all questions have been answered and the investigator is assured that the individual understands 
the implications of the privacy authorization form, the subject will be asked to sign the privacy 
authorization. The authorization remains in effect until revoked by the subject. The investigator 
will provide a copy of the signed privacy authorization form to each subject. Subjects who do not 
sign the privacy authorization form will not be permitted to participate in the study. 
16.5. 
Protocol Amendments and Emergency Deviations 
Changes to the research covered by this protocol must be implemented by formal protocol 
amendment. Amendments to the protocol may be initiated by the Sponsor or at the request of the 
investigator. In either case, a formal amendment cannot be initiated until the Sponsor has 
approved it, the investigator has signed it off, and it has been reviewed and has received approval 
or favorable opinion by the IRB or IEC. 
Emergency deviations or modifications may be initiated without the Sponsor’s or IRB/IEC 
approval or favorable opinion, only in cases where the change is necessary to eliminate an 
immediate apparent hazard to subjects. Emergency deviations or modifications must be reported 
to CRO/Sponsor and the IRB/IEC within five business days of the occurrence, or in accordance 
with applicable regulatory requirements. 
16.6. 
Monitoring and Auditing of the Study 
A clinical monitor, whether an employee of the Sponsor or its designated representative, has the 
obligation to follow this study closely. In doing so, the monitor will visit the clinical study sites 
at periodic intervals, in addition to maintaining necessary telephone and letter contact. The 
monitor will maintain current personal knowledge of the study through observation, review of 

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study records and source documentation, and discussion of the conduct of the study with the 
investigator and staff. Quality assurance auditors, whether an employee of the Sponsor or its 
designated representative, may evaluate the conduct of the study by the clinical study sites. 
These parties must have access to any and all study-related documentation including source 
documentation, regardless of location and format. The Sponsor audit reports will be kept highly 
confidential. 
16.7. 
Study Documentation 
As part of the responsibilities assumed by participating in the study, the investigator agrees to 
maintain adequate case histories for the subjects treated as part of the research under this 
protocol. The investigator agrees to maintain accurate source documentation and CRFs as part of 
the case histories. 
Study records are comprised of source documents, CRFs, and all other administrative 
documents, eg, IRB/IEC correspondence, clinical study materials and supplies shipment 
manifests, monitoring logs, Sponsor and CRO correspondence, etc. A study specific binder will 
be provided with instructions for the maintenance of study records. 
Source documentation is defined as any hand written or computer generated document that 
contains medical information or test results that have been collected for or is in support of the 
protocol specifications, eg, clinical lab reports, clinic notes, drug disbursement log, subject sign 
in sheets, subject completed questionnaires, telephone logs, ECGs, etc. All draft, preliminary and 
pre final iterations of a final report are also considered to be source documents, eg, faxed lab 
reports and hard copy lab reports, faxed initial results and hard copy, final report.  
CRO/Sponsor will supply CRFs. All requested information must be entered on the CRFs. Every 
effort should be made to complete all forms in their entirety. If an item is not available or is not 
applicable, this fact should be indicated; do not leave a space blank. Each set of completed CRFs 
must be reviewed, electronically signed and dated by the investigator.  
16.8. 
Laboratory Certification and Normal Values 
A central laboratory will be used for analysis for most of the clinical labs for this study. The 
central laboratory will provide the investigator, CRO, and Sponsor with laboratory 
certification(s), a dated copy of normal range values for the central clinical laboratory selected to 
analyze clinical specimens, and the lab director’s CV. If an exception is granted to use a local 
laboratory, the investigator must supply the CRO/Sponsor with laboratory certification, lab 
director’s CV and a current, dated copy of normal range values.  
16.9. 
Records Retention 
The investigator agrees to retain study records for the time periods stated below. The investigator 
agrees to contact CRO/Sponsor before destroying any study documentation. Should the 
investigator leave the site at which the study was conducted, CRO/Sponsor will be contacted 
regarding the disposition of document storage. 
Records will be retained until at least 2 years after the last approval of a marketing application in 
an ICH region and until there are no pending or contemplated marketing applications in an ICH 

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region or at least 2 years have elapsed since the formal discontinuation of clinical development 
of the investigational product. 
Dates marking the beginning of the final record retention periods will be sent in writing from 
CRO/Sponsor. If an investigator withdraws from the study (eg, relocation), the records will be 
transferred to a mutually agreed upon designee (ie, another investigator). This transfer is subject 
to Sponsor approval and will be documented in writing and a copy sent to the Sponsor. 
Electronic Data Capture/ePRO Data Archiving: 
In compliance with data retention requirements, and after the capture phase of the study is 
complete, the site will receive a copy of all eSource data and accompanying audit trail from the 
EDC and/or ePRO vendors. The vendors shall certify the integrity of the copy (certified copy) 
and send it on commonly readable storage material (CD or DVD); if necessary, software for 
viewing the data files and instruction on installation and use of the software will also be 
included. This read-only archive will be retained, protected, and made accessible by the site 
throughout the required retention period. 
16.10. 
Inspection of Records 
In the event of an inspection, the investigator agrees to allow representatives of the Sponsor, its 
representative, the Food and Drug Administration or other regulatory authorities’ access to all 
study records. The investigator will promptly notify CRO/Sponsor of all requests to inspect by 
government agencies and will promptly forward a copy of all such inspection reports. 
16.11. 
Financial Disclosure 
Prior to the start of the study, investigators will release sufficient and accurate financial 
information that permits CRO/Sponsor to demonstrate that an investigator and all sub-
investigators listed on the Form FDA 1572, if appropriate, have no personal or professional 
financial incentive regarding the future approval or disapproval of the study medication such that 
his or her research might be biased by such incentive. Investigators will provide an update of the 
above financial information at the end of the study and one year following the end of the study. 

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17. 
STUDY ACKNOWLEDGMENT 
I have read the foregoing protocol, D1050302, Version 4.0, “A 104-Week, Flexible-Dose, Open-
Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of 
Lurasidone in Pediatric Subjects”, and agree that it contains all necessary details for conducting 
this study and to conduct the study in strict accordance with the specifications outlined herein. 
By signing the protocol, the investigator agrees to keep all information provided by Sunovion 
Pharmaceuticals Inc. in strict confidence and to request the same from his/her staff and the 
Institutional Review Board/Independent Ethics Committee. Study documents provided by 
Sunovion Pharmaceuticals Inc. (protocols, Investigator Brochures, case report forms, and other 
materials) will be stored appropriately to ensure their confidentiality. The information provided 
by Sunovion Pharmaceuticals Inc. to the investigator may not be disclosed to others without 
direct written authorization from Sunovion Pharmaceuticals Inc., except to the extent necessary 
to conduct the study. 
I agree that no additional procedure(s) will be added during the conduct of the study except 
through protocol amendment by Sunovion Pharmaceuticals Inc. and after documentation of IRB 
or IEC approval. 
Investigator Signature: ____________________________________________________ 
Print Investigator Name: __________________________________________________ 
Date: ___________________________________________ 

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18. 
REFERENCES 
Barnes TRE. A rating scale for drug-induced akathisia. Br J Psychiatry 1989;154:672-676. 
Barnes TRE. The Barnes Akathisia Rating Scale – Revisited. J Psychopharmacology 
2003;17(4):365-370. 
Guy W. EDCEU Assessment Manual for Psychopharmacology – Revised (DHEW Publ No 
ADM 76-338). Rockville, MD, U.S. Department of Health, Education, and Welfare, Public 
Health Service, Alcohol, Drug Abuse, and Mental Health Administration, NIMH 
Psychopharmacology Research Branch, Division of Extramural Research Programs, 1976:534-
537. 
Kay SR, Opler LA, Fisbein A. Positive and Negative Syndrome Scale Manual. North 
Tonawanda, NY: Multi-Health Systems, 1994. 
Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K. The UKU side effect rating scale. A 
new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects 
in neuroleptic-treated patients. Acta Psychiatr Scand Suppl. 1987;334:1-100. 
Munetz MR, Benjamin S. How to examine subjects using the Abnormal Involuntary Movement 
Scale. Hospital and Community Psychiatry 1988;39:1172-1177. 
Opler LA, Kay SSR, Lindenmayer JP, Fiszbein A. Structured Clinical Interview for the Positive 
and Negative Syndrome Scale (SCI-PANSS). Toronto: Multi-Health Systems, 1992. 
Perkins DO, Stroup TS, Lieberman JA. Psychotic disorders measures. In Handbook of 
Psychiatric Measures. Washington, D.C.: American Psychiatric Association, 2000 p. 485-513.  
Scahill L, McDougle CJ, Williams SK, et al. Children's Yale-Brown Obsessive Compulsive 
Scale modified for pervasive developmental disorders. J Am Acad Child Adolesc Psychiatry. 
2006 Sep;45(9):1114-23. 
Schooler NR, Chengappa KNR. Adverse effects measures. In: Handbook of Psychiatric 
Measures. Washington, D.C.: American Psychiatric Association, 2000 p. 151-168. 
Sheehan DV. The Anxiety Disease. New York, Scribners, 1983. 
Simpson GM, Angus JWS. A rating scale for extrapyramidal side effects. Acta Psychiatrica 
Scandinavia, Suppl 1970; 212S:11-19. 
Williams JBW. Mental health status, functioning, and disabilities measures. In: Handbook of 
Psychiatric Measures. Washington, D.C.: American Psychiatric Association, 2000 p. 93-115. 
 
 

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APPENDIX A. CLINICAL LABORATORY TESTS 
The following laboratory tests are to be performed: 
 
Blood Chemistry Tests 
 
aspartate aminotransferase  
 
alanine aminotransferase  
 
albumin  
 
alkaline phosphatase  
 
bicarbonate  
 
blood urea nitrogen  
 
calcium  
 
chloride  
 
creatinine  
 
gamma-glutamyl transferase  
 
phosphorous  
 
potassium  
 
sodium  
 
total bilirubina 
 
total protein  
 
lactate dehydrogenase  
 
fasting (non-random) triglycerides 
 
fasting (non-random) serum cholesterol  
 
fasting (non-random) serum high-density lipoprotein cholesterol  
 
fasting (non-random) serum low-density lipoprotein cholesterol  
 
fasting glucose  
 
prolactin  
 
whole blood hemoglobin A1c 
 
creatine phosphokinase  
 
Endocrine Tests 
 
free thyroxine test 
 
thyroid-stimulating hormone test 
 
Hormonal Parameters 
 
follicle stimulating hormone (female subjects only) 
 
luteinizing hormone (female subjects only) 
 
testosterone (male subjects only) 
 
estradiol (female subjects only) 
 
serum human chorionic gonadotropin (β-hCG) (female subjects ≥ 11 years of age only) 
 
urine human chorionic gonadotropin (β-hCG) (female subjects ≥ 11 years of age only) 
 
Hematology Tests 
 
white blood cell count 
 
white blood cell differential 
 
eosinophilic leukocyte count 
 
basophilic leukocyte count 
 
neutrophil count 
 
lymphocyte count 
 
monocyte count 
 
platelet count 
 
hemoglobin  
 
blood hematocrit 
 
red blood cell count 

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red cell distribution width  
 
red blood cell indices: 
 
mean corpuscular volume 
 
mean corpuscular hemoglobin concentration 
 
mean corpuscular hemoglobin 
 
Urinalysis Tests 
 
color  
 
appearance  
 
total ketones  
 
urobilinogen  
 
bilirubin  
 
red blood cells 
 
leukocyte esterase  
 
nitrite  
 
pH  
 
protein  
 
specific gravity  
 
glucose  
 
microscopic evaluationb 
 
Urine Drug Screen 
 
amphetamines  
 
benzodiazepines  
 
barbiturates  
 
cocaine  
 
tetrahydrocannabinol  
 
ethanol  
 
methadone  
 
methamphetamine  
 
opiates  
 
phencyclidine  
a Bilirubin will be fractionated (direct serum bilirubin test/indirect serum bilirubin test) if elevated 2.0 times the 
upper limit of the normal range. 
b Microscopic evaluation will be performed if the Chemstrip 9™ (or equivalent dipstick analysis) indicates the 
presence of any significant abnormality. 
Table 9: 
Total Blood Drawn For Laboratory Tests 
Visit 
Total mL 
6E 
8.5 
10E 
8.5 
16E 
8.5 
22E 
8.5 
29E/ET 
8.5 
Total  
42.5 mL 
 

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APPENDIX B. POTENT INHIBITORS AND INDUCERS OF THE 
CYP3A4 ENZYME SYSTEM 
CYP3A4 Inhibitors: 
Azole antifungals 
• Butoconazole 
• Fluconazole 
• Itraconazole 
• Ketoconazole 
• Miconazole 
• Sulconazole 
• Tioconazole 
HIV protease inhibitors 
• Amprenavir 
• Indinavir 
• Nelfinavir 
• Ritonavir 
• Saquinavir 
Macrolide antibiotics 
• Clarithromycin 
• Dirithromycin 
• Erythromycin 
• Troleandomycin 
Miscellaneous 
• Nefazodone 
• Diltiazem 
• Verapamil 
• Amiodarone 
• Cimetidine 
• Grapefruit juice 
CYP3A4 Inducers: 
Barbiturates 
• Amobarbital 
• Butabarbital 
• Butalbital compound 
• Mephobarbital 
• Methohexital 
• Pentobarbital 
• Phenobarbital 
• Primidone 
• Secobarbital 
• Thiopental 
Miscellaneous 
• Carbamazepine 
• Hypericin (St. John’s Wort) 
• Phenytoin 
• Rifampin 
• Oxcarbazepine 
• Topiramate 
 
 

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APPENDIX C. DEFINITIONS FOR REPORTING ADVERSE EVENTS  
The investigator must assess the severity of the AE using the following: 
• Mild - awareness of event but easily tolerated. 
• Moderate - discomfort enough to cause some interference with normal activity. 
• Severe - inability to carry out usual activity. 
The investigator must assess the relationship of the AE to the study medication using the 
following: 
• Unrelated – improbable temporal relationship and is plausibly related to other drugs or 
underlying disease. 
• Unlikely - occurs with a temporal relationship to treatment administration that makes a 
causal relationship improbable, and in which other medications, chemicals, or underlying 
disease provide plausible explanations. 
• Possible - occurred in a reasonable time after study drug administration, but could be 
related to concurrent drugs or underlying disease. 
• Probable - occurred in a reasonable time after study drug administration, is unlikely to 
be attributable to concurrent drugs or underlying disease, and there is a plausible 
mechanism to implicate the study drug.  
• Related - occurred in a reasonable time after study drug administration and cannot be 
explained by concurrent drugs or underlying disease. The adverse event should respond 
to dechallenge/rechallenge, however, this is not mandatory before assigning a definite 
causality. 
Frequency will be defined using the following terms and definitions: 
• Once – an isolated episode. 
• Intermittent – occurs on two or more separate occasions. 
• Continuous – does not abate from date of onset to date of resolution. 
The action taken regarding study drug will be defined as follows: 
• Dose Not Changed – no change. 
• Dose Increased. 
• Dose Reduced. 
• Drug Interrupted – study drug stopped temporarily. 
• Drug Withdrawn – study drug stopped permanently. 
• Not Applicable.