Implementation and Evaluation of the Pathway Platform: A Digitally Enabled Care Pathway to Improve Depression Key Performance Indicators and Patient Outcomes in Primary Care Clinics
Phase: NA
Conditions: Major Depressive Disorder
Sponsor: Wake Forest University Health Sciences

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Implementation and Evaluation of the Pathway Platform:  
A Digitally Enabled Care Pathway to Improve Depression Key Performance Indicators 
and Patient Outcomes in Primary Care Clinics 
 
Principal Investigator: 
Dr. David Kemp 
Behavioral Health Director 
Advocate Health Care 
David.Kemp@aah.org 
 
Collaborators: 
Takeda Pharmaceuticals USA, Inc.  
Lundbeck LLC, USA 
 
Mobile App for Patients and Care Team Interface  
Powered by Fora Health, a Ctrl Group Ltd Product 
 
 

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TABLE OF CONTENTS 
SUMMARY ................................................................................................................................... 4 
Study Title ................................................................................................................................... 4 
Objectives ................................................................................................................................... 4 
Design and Outcomes ................................................................................................................. 4 
Sample Size and Population ....................................................................................................... 4 
LIST OF ABBREVIATIONS ...................................................................................................... 7 
1 
STUDY OBJECTIVES ....................................................................................................... 8 
1.1 
Primary Objective ........................................................................................................... 8 
1.2 
Secondary Objectives ..................................................................................................... 8 
2. 
BACKGROUND AND RATIONALE ............................................................................... 8 
2.1 
Background ..................................................................................................................... 8 
2.2 
Study Rationale ............................................................................................................... 9 
3. 
STUDY DESIGN ............................................................................................................... 10 
3.1 
Performance among participating clinics post-implementation ................................... 11 
3.2 
Retrospective Assessment: pre-implementation performance at the clinic level (before 
Pathway Platform implementation) .............................................................................. 11 
4. 
SELECTION AND ENROLLMENT OF PARTICIPANTS ........................................ 12 
4.1 
Inclusion ........................................................................................................................ 12 
4.2 
Exclusion ...................................................................................................................... 13 
4.3 
Study Enrollment Procedures ....................................................................................... 14 
4.4 
Pathway Platform .......................................................................................................... 14 
4.4.1 Pathway App ............................................................................................................. 15 
4.4.2 Electronic Medical Record integration ..................................................................... 15 
4.4.3 Educational Scaffolding ............................................................................................ 15 
4.5 
Study Duration .............................................................................................................. 16 
5. 
STUDY PROCEDURES ................................................................................................... 16 
5.1 
Schedule of events ........................................................................................................ 16 
5.2 
Description of study evaluations ................................................................................... 18 
6. 
SAFETY ASSESSMENTS ............................................................................................... 18 
6.1 
Adverse Events Related to the Pathway Platform ........................................................ 18 
6.2 
Change in Participant Suicidal Ideation ........................................................................ 19 
7. 
INTERVENTION DISCONTINUATION ...................................................................... 20 

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8. 
STATISTICAL CONSIDERATIONS ............................................................................. 20 
8.1 
General Design and Hypothesis .................................................................................... 20 
8.2 
Sample size and randomization .................................................................................... 20 
8.3 
Outcomes ...................................................................................................................... 21 
8.3.1 Primary outcome ....................................................................................................... 21 
8.3.2 Secondary outcome ................................................................................................... 21 
8.3.3 Exploratory outcomes ............................................................................................... 22 
8.3.4 Patient and provider in-depth interviews .................................................................. 23 
8.3.5 System level performance ......................................................................................... 24 
8.4 
Data analysis ................................................................................................................. 24 
9. 
PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................ 25 
9.1 
Institutional Review Board (IRB) Review .................................................................... 25 
9.2 
Informed Consent Forms .............................................................................................. 25 
9.3 
Participant Confidentiality ............................................................................................ 25 
9.4 
Study Discontinuation ................................................................................................... 26 
10. 
TAKEDA 
MARKETED 
PRODUCT 
ADVERSE 
EVENT 
REPORTING 
REQUIREMENTS ............................................................................................................ 26 
10.1 
Special Situation Reports and Product Quality Issues .................................................. 26 
10.2 
Procedures ..................................................................................................................... 27 
11. 
PUBLICATION OF RESEARCH FINDINGS .............................................................. 27 
12. 
REFERENCES .................................................................................................................. 27 
 

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SUMMARY 
Study Title  
Implementation and Evaluation of a Digitally Enabled Care Pathway to Improve Depression Key 
Performance Indicators and Patient Outcomes in Primary Care. 
Objectives  
The primary objective of this study is to determine whether implementing the Pathway Platform 
in primary care improves adherence to measurement-based care practices. 
Secondary objectives include determining whether implementing the Pathway Platform improves 
additional clinical process measures and depression response and remission outcomes. 
Design and Outcomes   
A pre- and post- study design is utilized to assess the impact of implementing the Pathway Platform 
in the primary care setting. Up to 20 primary care sites will be identified to participate in the study. 
Care team members involved in depression management will receive education on evidence-based 
clinical practices for depression care, such as measurement-based care practices and shared- 
decision making. Clinics with behavioral resources will also receive additional education on 
behavioral health integration. Training on how to onboard patients to use the Pathway Platform 
and utilize electronic medical records to view data collected in the Pathway Platform will also be 
provided. Study outcomes identified in this protocol will be assessed among 200 patients who will 
be enrolled in the Pathway Platform (post-implementation cohort). Outcomes will also be assessed 
in another 200 patients from the same participating clinics prior to study implementation (pre-
implementation cohort). Implementation success will be evaluated by comparing study outcomes 
among the two cohorts with a total sample size of 400 patients (of which 200 will receive the 
intervention and 200 will not). The primary outcome is PHQ-9 utilization over six months and will 
be compared between the pre- and post- implementation cohorts. Additional process measures will 
be compared, including shared-decision making, medication adjustments, referrals to behavioral 
health, primary care follow-up post hospitalizations, and remission and response. Data collected 
in the Pathway Platform will also be evaluated to explore pre-defined patient outcomes. Additional 
outcomes will be explored in data captured from patients who continue to use the app beyond the 
initial 6 month study period.   
Sample Size and Population  
The study will take place in up 20 primary care clinics within Advocate Aurora Health Care that 
are representative of different geographic locations, patient populations, and care models for 

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depression management, including behavioral health integration models.   
 
The Pathway Platform consists of a mobile app for patients and a care team interface that can be 
accessed through Epic. We intend to enroll 200 patients who meet the eligibility criteria for this 
study and agree to download the Pathway Platform.  An additional 200 patients will be identified 
from the same participating clinics to form the pre-implementation cohort. These are patients who 
visited the participating clinics at least 6 months prior to study implementation; they will not be 
actively enrolled into the study and their data will be collected retrospectively through chart 
reviews and electronic data pulls. 

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LIST OF ABBREVIATIONS 
AE 
Adverse Event 
APA 
American Psychiatric Association 
APPS 
Mobile Health Applications 
ASEX 
Arizona Sexual Experience Scale 
CCM 
Collaborative Care Model 
DSST 
Digit Symbol Substitution Test 
ED 
Emergency Department 
EMR 
Electronic Medical Record 
GAD 
Generalized Anxiety Disorder 
GAS 
Goal Attainment Scale 
GAD 
Generalized Anxiety Disorder  
IRB 
Institutional Review Board 
IQR 
Interquartile Range 
MBC 
Measurement Based Care  
MDD 
Major Depressive Disorder 
PAM-13 
Patient Activation Measure 
PDQ-D5 
Perceived Deficits Questionnaire- Depression 
PHQ-2 
Patient Health Questionnaire-2 
PHQ-9 
Patient Health Questionnaire Depression 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
PSD-6 
PROMIS Sleep Disturbance 6a 
PTSD 
Post-Traumatic Stress Disorder 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SDM 
Shared-Decision Making Model 
SSR 
Special Situation Report 
WSAS 
Work and Social Adjustment Scale  
WHO-5 
World Heart Organization- Five Well Being Index 
 
 

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1 
 STUDY OBJECTIVES 
1.1 Primary Objective 
The primary objective of this study is to determine whether implementing the Pathway Platform  
in primary care improves adherence to measurement-based care practices. We hypothesize 
improved clinical processes in measurement-based care, measured by PHQ-9 utilization among 
patients attending clinics post-implementation compared to those attending clinics pre-
implementation.  
1.2 Secondary Objectives 
Secondary objectives include determining whether implementing the Pathway Platform improves 
additional clinical process measures and MDD response and remission outcomes. Patient 
outcomes and Pathway Platform utilization will be explored among patients using the Pathway 
Platform.  
2. 
BACKGROUND AND RATIONALE  
2.1 Background  
Health-related technology solutions that utilize mobile phones, known as mobile health 
applications (apps), have the potential to expand health interventions beyond the traditional face-
to-face patient visit. For the healthcare provider, mobile apps can offer low cost and easily scalable 
interventions to monitor and improve services to patient populations that are difficult to retain in 
treatment and may promote better health.1 Uptake of health-related mobile apps has increased in 
recent years as technology barriers such as access, knowledge, and product usability have 
improved, reducing obstacles for ‘digitally excluded’ subpopulations (e.g., poor, rural, and older).2 
Consensus exists that the availability of a mobile app for depression management that is user 
friendly and aligns with busy office practice would likely be adopted by end users.3-4 Patients with 
depression and their treating provider may benefit from the use of a mobile health app to assist in 
disease management.   
American Psychiatric Association (APA) clinical guidelines recommend measurement-based care 
(MBC) in treating depression, defined as a psychiatric evaluation including quantitative measures 
of symptoms, level of functioning, and quality of life. APA guidelines cite several studies that 
have shown benefits in using quantitative measures during an initial screening and also for 
monitoring depression throughout treatment.5A mobile app may promote MBC by allowing 
patients to remotely answer quantitative instruments, such as the PHQ-9, which can be uploaded 
into their electronic medical records (EMR) for in office visits and physician monitoring.5 A study 

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by Torous et al. found that while in person paper scores and app scores were strongly correlated 
(r=.84), PHQ-9 app scores were consistently higher over a 30 days period.6 An overall conclusion 
of this study was that collecting PHQ-9’s through a mobile app may be more sensitive than the 
traditional PHQ-9.6 Increased consultation times are often cited as a barrier to MBC 
implementation.5,7 An app may save time as the physician will only need to review PHQ-9 instead 
of administering the questions during the visit. Although the validity of the PHQ-9 has been shown 
in studies, further research is needed to assess its ability to track outcomes of depression therapy 
over time.7 This systematic approach to treatment may have positive effects on the patient-
physician relationship and enhance shared decision making.5  
A shared decision-making (SDM) model of interaction can foster patient provider engagement as 
well as increase patient satisfaction.8 Several studies have found that individuals suffering from a 
mental illness want a larger part in the treatment decision making process.9 A common barrier for 
SDM is a physician choosing a treatment plan that is not mutually agreed on by both the physician 
and patient. This can be overcome by increasing education and further clarifying the benefits of a 
specific treatment plan to align with the patient’s values.9 Incorporating a SDM model may help 
increase adherence to drug treatment in a primary care setting.8 Mobile technology can enhance 
SDM. 
A collaborative care model (CCM) that involves behavioral health integration within primary care 
is another evidence-based practice that enhances depression management. Collaborative care is a 
systematic approach that improves patient education and integrates mental health professionals or 
other care extenders, such as nurses, into the primary care clinic to help primary care physicians 
provide treatment in conformity with evidence-based guidelines.10 CCM’s have been shown to 
improve outcomes of patients with major depression.11  
We hypothesize that integrating the Pathway Platform to support measurement- based care and 
shared decision- making, will improve the clinic workflow, depression management, adherence to 
medication, patient-provider engagement and improve depression outcomes and care.   
2.2 Study Rationale  
Major Depressive Disorder (MDD) is a serious public health concern worldwide with ample 
documentation demonstrating that it is one of the leading contributors to the global burden of 
disease and is currently the leading cause of disability worldwide.12-13 Moreover, the economic 
burden of MDD is estimated to total $210.5 billion with approximately 50% of the cost being 
attributable to impairment in role function.13-15  
A selection of mobile apps has been developed and are available for depression management. 

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However, many are patient facing only and have not implemented a care team interface. Most of 
these apps have been assessed for effectiveness in a research setting only and have not been 
integrated within clinic workflow resulting in lack of adoption by the care team and by healthcare 
systems.  
This study builds on prior work that piloted a mobile App for feasibility and depression 
management, the Pathway app. The first iteration of the Pathway App included patient reported 
outcomes related to depression, wellbeing, cognitive symptom tracking, medication adherence and 
side effects. Pilot results confirmed the feasibility of using the Pathway app in patients with 
depression and showed a trend in patient engagement in the app arm, albeit in a small sample size. 
The Pathway pilot and feasibility study included qualitative assessments with patients and 
clinicians that highlight the need to enhance the flow of real time data shared with the care team 
and the need to integrate within the care team work flow including real time data sharing of the 
patient’s app data within the EMR16. It also highlighted the need for care team education on 
measurement-based care, shared-decision making, and collaborative care and on how to utilize the 
Pathway App to improve these processes. Building on these results we created the Pathway 
Platform which includes a newer iteration of the Pathway App along with real time patient level 
data shared with the EMR integration in real-time and educational program both care team and 
patient facing. 
We aim to implement a digitally enabled care pathway referred to as the Pathway Platform and 
assess its impact on measurement-based care and other evidence-based processes. The primary 
objective is to determine whether PHQ-9 utilization, a measurement- based practice, is greater 
after is the Pathway Platform implemented. 
3. 
STUDY DESIGN 
We will use a pre- post- study design to assess the impact of implementing the Pathway Platform 
in the primary care setting. Clinic performance and select patient outcomes will be compared 
before and after implementation. Additional patient outcomes will be assessed after 
implementation among patients using the Pathway Platform (Figure 1).  
This study will be performed within primary care clinics in Advocate’s Health Care System. 
Advocate is the largest healthcare provider in the state of Illinois with 12 hospitals, 20 health 
centers, and 250+ care sites. It is one of the largest Accountable Care Organizations in the United 
States caring for over 2 million patients annually. General practitioners provide diagnoses, 
treatment, and clinical care for adults ages 18 and over with chronic diseases, which often includes 
MDD. 

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3.1 
Performance among participating clinics post-implementation 
The Pathway Platform will be implemented in up to 20 primary care sites within the Advocate 
Aurora Health system and enroll a total of 200 patients for six-month duration. The visit where the 
patient has been onboarded to the Pathway Platform will be the enrollment visit (Figure 1).  During 
the post- implementation period, data on patient outcomes will be collected through the Pathway 
Platform. At the end of the study an electronic and manual chart review for patients using the 
Pathway Platform will be conducted among participating clinics and performance related to 
measurement-based care, shared decision making and collaborative care, where applicable, will 
be assessed over the post-implementation period.    
 
3.2 
Retrospective Assessment: pre-implementation performance at the clinic level 
(before Pathway Platform implementation)  
To assess Advocate's primary care sites performance pre-implementation, an electronic and 
manual chart review will be conducted from the same Advocate primary care clinics participating 
in the implementation study. Patients with a clinic visit at least 6 months prior to implementation 
(index visit) of the Pathway Platform and meeting the inclusion criteria for enrollment in the study, 
will be included in this analysis (figure 1). Patient history will be evaluated for three months prior 
to index visit to confirm eligibility. The goal is to capture patients with a new start, dose adjustment 
or switch of an antidepressant medication 6 months prior to the implementation index date (three-
month inclusion window for patient identification). Six months of patient history will be 
“retrospectively” collected for this baseline patient cohort to assess the primary outcome, defined 
as PHQ-9 utilization, and other secondary outcomes outlined in the protocol.  This analysis will 
serve as the comparison control for the primary and secondary outcomes to compare performance 
at the same clinics pre and post-implementation of the Pathway Platform. Depending on the 
number of eligible patients identified per site (20 per site), group level matching for age and sex 
may be conducted. The primary endpoint will be the proportion of patients with at least 2 PHQ-9 
scores. 
 
 
 
 
 
 
 
 

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Figure 1: Study schematic   
 
4.   SELECTION AND ENROLLMENT OF PARTICIPANTS 
Patients will be recruited from up to 20 primary care clinics within Advocate Aurora Health that 
have agreed to implement the Pathway Platform. We aim to identify clinics that are representative 
of different geographic locations, patient populations, and care models for depression 
management, including behavioral health integration models. We will balance clinic diversity with 
feasibility to conduct this study. For example, we will only include clinics that have integrated 
Epic within their workflow so that the care team can easily access data collected from the patient 
in the Pathway Platform. We will also focus on clinics that have a large volume of patients 
diagnosed with depression as well as clinics that have care team members that are interested and 
engaged in depression care.  
All care team members who care for patients with depression will be invited to participate in this 
implementation study and will have access to an online educational resource center. Patients 
fulfilling the following criteria will be eligible to download and use the Pathway Platform: 
4.1  Inclusion 
1. Adult aged 18 and above  
* Primary and secondary outcomes will be evaluated at 6 months, data collected beyond 6 
months will be used for exploratory analysis 

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2. Diagnosis with major depressive disorder or reference to “clinical depression” in patient 
charts. See Appendix 1 for ICD codes for major depressive disorders  
3. Recently prescribed monotherapy antidepressant medication (defined as new start, 
medication switch, or dose change in the past 3 months (Appendix 2). 
4. Patients with inadequate response or tolerability concerns determined based on A PHQ-2 
score of 3 or greater, or a PHQ-2 <3 with a PHQ-9 score of 5 or greater recorded in medical 
records in the past 6 weeks or during screening,  
5. Able and willing to provide informed consent 
6. Able to use the Pathway Platform based on clinician’s judgment, e.g.  owns an iPhone 
version 5 or later or smartphones with Android operating systems, have an active data plan or 
regular WiFi access. 
4.2   Exclusion 
1. Missing PHQ-2/PHQ-9 score in the past 6 weeks and/or unable to perform PHQ-2/PHQ-9 at 
index visit  
2. Diagnosis with bipolar depression, schizophrenia, and/or schizoaffective disorder, 
(Appendix 1).  
3. Patient no longer under primary care for depression and has transitioned to a psychiatric care 
team (i.e., Psychiatrist, Advance Practice Psychiatric Nurse, Psychiatric Nurse Practitioner, 
Psychiatric Physician Assistant).  
4. Lack of functional English literacy (indicated by primary language in EMR). 
 
 

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4.3  Study Enrollment Procedures 
This is a real-world implementation study with minimal interaction between the study team and 
patients. To address recent virtual visits in primary care due to COVID-19 and for the safety of the 
study team, study methods were developed to adapt virtual patient recruitment and e-consent 
during existing virtual visit processes. An in person consenting process is also available for in 
person clinic visits, when safe and appropriate, and will be supported by a study team member 
present at recruiting clinics. 
 
Study team will review clinic schedules routinely for visits scheduled the next day and will flag 
potentially eligible patients and will discuss the list with the health care team. These patients will 
be introduced to the study opportunity by care team members during routine clinic visits.  
- 
Consenting in person: If the patient is interested, they will be roomed with a study team 
member who will confirm study eligibility and provide written informed consent. If the 
patient is eligible and provides consent, the study team will share a secure message with a 
link for the Pathway App with the patient and the patient will be able to activate the 
Pathway App and start entering data. The secure message will be shared with the patient 
via AAH’s secure patient portal. Or through an email for patients who have not activated 
their portal. The invitation message in the email will include an individualized link to 
download the App with a unique code specific to that patient to ensure security. 
- 
e-Consenting virtually: If the patient is interested, the care team member will inform the 
research team, who will confirm eligibility and send a secure invitation to the patient (AAH 
patient portal or email with unique link and code). The invitation message includes a link 
to start the e-consenting process and that includes study contact information to allow 
patients to reach out to the study team with any questions during e-consenting or during 
the study. The link in the message will direct the patient to start the e-consenting process. 
The patient will not be able to download the app until they have completed the e-consenting 
process. Patient e-consent will be obtained in REDCap using a finger or stylus-directed 
signature on the mobile phone, with data including attestation of individual identity and 
time and date of signing. Upon completion, participants will be able to download a pdf 
copy of the signed e-consent form. The patient will then be invited to download the 
Pathway App via another secure message with a link including details for the patient to 
activate the mobile app and start entering data. 
4.4  Pathway Platform 
The Pathway Platform consists of three components:  

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4.4.1 Pathway App 
Pathway is a mobile application designed to gather health information related to the management 
of depression to enhance patient clinical engagement and guide patient care. The patient facing 
interface includes a digital assistant that allows patients to interact with the Pathway Platform in a 
chat-based conversational text interface. The information collected from the patient is intended to 
assist the care team in managing the patient’s depression through enhancing measurement-based 
care and shared-decision making - enhancing patient-provider engagement and ultimately patient 
outcomes. The study will deploy the most recent iteration of the Pathway Platform. Earlier 
iterations were piloted in four primary care clinics.16 Feedback from this pilot was used to enhance 
Pathway Platform functionality. The current iteration of the Pathway Platform, which is the version 
that will be used in the implementation study described in this protocol, prompts patients to 
complete four scales to assess depression status biweekly (Patient Health Questionnaire [PHQ-9] 
and Perceived Deficits Questionnaire-Depression [PDQ-D5]), quality of life (World Health 
Organization- Five Well Being Index [WHO-5]), and cognition (Digit Symbol Substitution Test 
[DSST]).7,17,18,19 The Pathway Platform also includes a daily evening check-in with the patient to 
collect information on medication adherence and side effects. Patients reporting side effects related 
to sleep are prompted to complete the PROMIS Sleep Disturbance 6a and patients reporting side 
effects related to sexual dysfunction are prompted to complete the Arizona Sexual Experience 
Scale (ASEX).20,21 An optional functionality of the Pathway Platform is to set and track goals using 
the Goal Attainment approach adapted for depression during clinic visits with a healthcare 
provider.22 In addition, the Pathway Platform includes patient facing education for the patient on 
how to use the Pathway Platform to collect data as well as how to prepare for a visit with health 
care providers, set and assess progress towards goals and self-management. For purposes of 
evaluating this implementation study three additional scales assessing patient-provider 
engagement and functional improvement will be deployed through the Pathway Platform at 
baseline and subsequently every 6 months until the end of the study (Patient Activation Measure -
13[PAM-13], CollaboRATE, and Work and Social Adjustment Scale [WSAS]).23,24,25  
4.4.2 Electronic Medical Record integration 
Data collected in the Pathway Platform is electronically transmitted and stored in the patient’s 
EMR. This data is accessible to the care team and provides a longitudinal summary that may assist 
in decision making and depression management. Providers can view this data either before or 
during the patient visit and use it to discuss future depression management.  
4.4.3  Educational Scaffolding  
An online Educational training program was developed using evidence-based medicine building 

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on measurement-based care and shared-decision making concepts as they relate to depression 
management. Educational material describes how the Pathway Platform can help care team 
members in clinical processes related to these process improvement measures. In clinics using a 
collaborative care model additional education material specific to this care model is provided. 
Educational material housed in an online resource center which includes reading material, 
presentations, and videos. Additionally, up to three audit and feedback sessions will be conducted 
for each participating clinic. The objectives of audit and feedback sessions are to benchmark 
performance measures, including shared decision making, reflect on current clinical practice and 
improvement strategies, and setting team-based action plans. Care team members who manage 
depression must complete specific training before they are able to enroll patients and begin using 
the Pathway Platform. 
A training manual was also developed for patients. The manual describes the Pathway Platform 
functionality, as well as, how to use and interpret the data collected.   
3.3 
Study Duration 
Patients will be enrolled in the study for a minimum duration of 6 months with the option to 
continue using the app at that time to a common study end date of January 7, 2023 ( access to in-
app final study evaluations will end  January 21, 2023). Data from the Pathway Platform will be 
collected prospectively for the duration of the patient’s participation.  Process measures will be 
collected retrospectively from the EMR and through manual chart review after 6 months of 
enrollment and at the end of the study(post-implementation) and over a 6-month period prior to 
implementation (pre-implementation).   
5.  STUDY PROCEDURES 
5.1  Schedule of events 
 

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Table 1: Schedule of evaluations 
 
 
 
 
 
 
Pre- 
electronic 
and 
manual 
chart 
reviews  
Complete 
education 
by care 
team 
Screening  
Baseline 
assessment 
6 month Assessment 
  
Final assessment  
 
Study Day/Week: 
 
Day -1 
Day 0 
Day 1 
Day 168 - 172^ 
 
Study end 
 
Visit Windows (Days): 
 
 
 
 
 
 
 
 
Source 
 
 
EMR/ 
patient 
scheduling 
Pathway 
Platform 
Pathway 
Platform 
EMR and 
Manual 
Review 
Pathway 
Platform 
EMR and 
Manual 
Review 
Patient electronic screening 
 
 
X 
 
 
 
 
 
Informed consent  
 
 
X 
 
 
 
 
 
Onboarding 
 
 
X 
 
 
 
 
 
Demographic characteristics  
X 
 
 
 
 
 
 
 
Number of PHQ-9 scores documented 
X 
 
 
 
X 
X 
X 
X 
Treatment adjustments  
X 
 
 
 
X 
X 
X 
X 
Shared decision making (OPTION-12 
and CollaboRATE) 
X 
 
 
 
X 
X 
X 
X 
Referral to behavioral health 
X 
 
 
 
 
X 
 
X 
PHQ-9 scores 
X 
 
 
 
X 
 
X 
 
Emergency room visits 
X 
 
 
 
 
X 
 
X 
Emergency room visits due to mental 
illness  
X 
 
 
 
 
X 
 
X 
Hospital admissions 
X 
 
 
 
 
X 
 
X 
Follow up after emergency room and 
hospital visits 
X 
 
 
 
 
X 
 
X 
Hospital admissions due to mental 
illness 
X 
 
 
 
 
X 
 
X 
Healthcare resource utilization 
 
 
 
 
 
 
 
 
Outpatient visits including phone calls 
X 
 
 
 
 
X 
 
X 
Outpatient visits including phone calls 
due to mental illness  
X 
 
 
 
 
X 
 
X 
Remission and response (using PHQ-9 
data) 
X 
 
 
 
X 
 
X 
 
PAM 13 *** 
 
 
 
X 
X 
 
X 
 
CollaboRATE**, ***  
 
 
 
X 
X 
 
X 
 
WSAS *** 
 
 
 
X 
X 
 
X 
 
PHQ-9 
 
 
 
X 
X 
X 
X 
X 
WHO-5  
 
 
 
X 
X 
 
X 
 
PDQ-D5 
 
 
 
X 
X 
 
X 
 
Medication adherence  
 
 
 
X 
X 
 
X 
 
Side effects 
 
 
 
X 
X 
 
X 
 
PSD-6 (only if reporting side effects of 
sleep problems) 
 
 
 
X 
X 
 
X 
 
ASEX (only if reporting side effects of 
sexual problems) 
 
 
 
X 
X 
 
X 
 
Goal Setting 
 
 
 
X 
 
 
 
 
Goal Attainment 
 
 
 
 
X 
 
X 
 
App analytics  
 
 
 
X 
X 
 
X 
 
Report analytics  
 
 
 
X 
X 
 
X 
 
Educational material analytics  
 
 
 
X 
X 
 
X 
 
In depth interviews (Patients and 
Clinicians) 
 
 
 
 
 
 
X 
 
Adverse Events* 
X 
 
X 
X 
X 
 
X 
X 
Serious Adverse Events 
X 
 
X 
X 
X 
 
X 
X 
^Day 168 reflects end of initial 24 week study period in which the final set of care questionnaires are available for completion (PHQ-9, WHO-5 and 
PDQ-D5), these expire within 3 days.  Day 172; The off-boarding process is available, including the research questions (PAM-13, WSAS, 

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CollaboRATE), these  expire after 30 days.   
*If during the conduct of the study, a health care professional or patient spontaneously reports an Adverse Event or a serious adverse event to a Takeda 
product; such information should be reported to the sponsor. As such reports are spontaneously notified, causality of any AEs should be assumed unless 
there is evidence to the contrary; **CollaboRATE  will also be asked within the App at Day 84 with a 30 day window for completion during patient 
enrollment. ***PAM 13, CollaboRATE and WSAS; the App will trigger response to these questionnaires every 6 months until study end (note; if patient 
completed these questionnaires within 4 weeks of study end point, they will not be re-deployed for completion at end of study). 
5.2  Description of study evaluations  
1. EMR data pulls and manual chart reviews: EMR data and manual chart review data will be 
collected from two cohorts of patients: (1) patients attending clinics after implementation 
(post- implementation cohort) and (2) patients attending clinics before implementation 
(pre-implementation). For the pre-implementation cohort, data will be collected over a six-
month period.  For the post-implementation cohort, data will be collected from the time of 
study implementation until the end of the study. 
2. Pathway Platform data and analytics: Data on patient outcomes and Pathway Platform 
usage will be collected throughout the study starting at day 1 and ending on the final day 
of the patient’s participation (i.e. 6 months, common study end date or patient withdrawl). 
Similarly, data on report usage by care team will be collected throughout the study.  
3. Educational resource center analytics: The number of times material in the resource center 
is viewed will be recorded between day 1 and the end of the study.  
6.  SAFETY ASSESSMENTS  
6.1  Adverse Events Related to the Pathway Platform 
No adverse events (AEs) are expected in this minimal risk study related to the Pathway 
Platform; however, all serious adverse events (SAEs) that are spontaneously reported 
during the study period will be collected.   
 
  
A SAE is defined as an adverse event, reported during the implementation study of the 
Pathway Platform, in the view of either the investigator or sponsor, results in any of the 
following outcomes:  
 
a. Death  
b. Life-threatening adverse event  
c. Inpatient hospitalization or prolongation of existing hospitalization (for > 24 
hours)  
d. Persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions  
e. Congenital anomaly/birth defect.  

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f. 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 participant and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition.  
 
The following information will be collected for any SAE that is reported: 
 
• Event details 
• Start and stop date 
• Frequency 
• Intensity 
• Investigator’s opinion of the causal relationship to study procedure(s), including 
the details of the suspected procedure 
• Outcome of event 
• Severity 
 
Causality to study procedures will be determined for all SAEs and deemed “related” or 
“not related” to the intervention.  Severity will be assessed as mild (event is transient 
and easily tolerated by the subject), moderate (event causes the subject discomfort and 
interrupts the subjects’ usual activities), or severe (event causes considerable 
interference with the subject’s usual activities).  The start date of the SAE is the date 
that the first signs or symptoms were noted.  The stop date is the date on which the 
subject recovered, the event resolved, or the subject died.  
 
All SAEs, along with the information bulleted above, will be compiled and included in 
the final study report.  SAEs will be reported to Takeda within 24 hours of becoming 
aware of the event. 
 
6.2    Change in Participant Suicidal Ideation 
Patients using the Pathway Platform will answer biweekly PHQ-9 surveys, during 
which Item 9 asks about the frequency of suicidal ideation.  It is possible that a patient 
will report a change in suicidal ideation in the course of responding to this question.  In 
the event that a patient responds affirmatively to this question, the patient will receive a 
pop-up notification that s/he should contact his/her health care provider or emergency 
services immediately.  This instruction is what is given in routine clinical practice. The 

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data from the Pathway Platform is not monitored in real time by care teams. Patients 
will be informed via consent that the information provided to the Pathway Platform is 
not directly or continuously monitored. As an additional item of note, data from the 
Pathway Platform may be delayed and/or not received by the EMR if device is unable 
to transmit data.  
 
This information will also be included in the patient consent and will be explained to 
the patient by the Care Team during the consent process. 
7.  INTERVENTION DISCONTINUATION  
Patients are not required to use the Pathway Platform and can choose to discontinue at any time.  
Adherence to use will be tracked and reported for analytical purposes.  
8.  STATISTICAL CONSIDERATIONS 
8.1  General Design and Hypothesis 
The following hypotheses will be examined: 
Primary hypothesis: PHQ-9 utilization will be greater after implementation compared to before 
implementation of the Pathway Platform.  
Secondary hypothesis: Provider processes and patient depression related outcomes will have 
greater improvements in patient outcomes after implementation of the App compared to previous 
practice patterns. 
8.2  Sample size and randomization 
The primary outcome for this study is PHQ-9 utilization. Assuming 75% PHQ-9 utilization prior 
to implementation of the Pathway Platform and 90% PHQ-9 utilization after implementation of 
the Pathway Platform, we will need 100 patients per group, for a total of 200 patients, assuming 
80% power and a 2-sided alpha of 0.05 using Pearson chi square test for two independent 
proportions. To allow for subgroup analyses the sample will include 200 patients per group, for a 
total of 400 patients; 200 patients will comprise the “post-implementation” cohort and 200 will 
comprise the “pre-implementation” cohort. Table 2 presents additional sample size calculations 
based on different assumptions of PHQ-9 utilization.  
 
Table 2: Sample size calculations based on different assumptions of PHQ-9 utilization, alpha = 
0.05, Power = 80%.  

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PHQ-9 
utilization 
pre-
implementation  
PHQ-9 
in 
Pathway 
post- 
implementation  
N patients per group 
75% 
80% 
1,094 per group  
75% 
90% 
100 per group 
75% 
95% 
49 per group 
50% 
65% 
170 per group 
50% 
80% 
30 per group 
50% 
90% 
20 er group 
8.3  Outcomes 
8.3.1  Primary outcome 
The primary process outcome is PHQ-9 utilization over a six-month period. For purposes of this 
study, PHQ-9 utilization will be defined as documentation of at least 2 PHQ-9 scores in the EMR 
over the initial 6-month study period. The proportion of patients who meet this definition will be 
compared between patients attending clinics pre- and post- implementation of the Pathway 
Platform. Additional analyses exploring the number of PHQ-9s over the study period will also be 
conducted.  
8.3.2  Secondary outcome 
Process outcomes: The following secondary process outcomes will be compared between patients 
attending clinics pre- and post- implementation of the Pathway Platform.  
• Measurement- based care: The proportion of patients reflecting measurement-based care 
informed MDD treatment adjustments in their charts, defined as at least one dose change, 
medication switch, or add on medication during the study period. The frequency and types 
of treatment adjustments will also be explored.  
• Shared- decision making: The proportion of patients reflecting shared-decision making, 
using the OPTION12 Tool framework.26 The tool will be modified by adding a thirteenth 
domain inquiring about goal setting (Asking the patient or caregiver about goals of 
treatment). The frequency and domains of shared-decision making will also be explored in 
a manual chart review and a variable added to assess if the clinician documented asking 
the patient about their goals of treatment. 
 
• Referrals to behavioral health: The proportion of patients with at least one referral will be 
compared. The frequency and types of referrals will also be explored.  
• Follow-up after hospitalization for mental illness: The proportion of hospitalized adults 
who receive follow-up within 7 days of discharge and within 30 days of discharge. 
• Follow-up after emergency department visit for mental illness: The proportion of adults 

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who receive follow-up within 7 days of discharge and within 30 days of ED visit. 
• Healthcare resource utilization: Number and costs associated with hospital admission, 
length of stay, emergency room admissions, and encounters with outpatient clinics. Costs 
will be calculated using USA national average costs for inpatient and outpatient visits or 
using an average Advocate Health Care system cost.  
 
Patient clinical outcomes: The following outcomes will be compared between patients 
attending clinics pre- and post- implementation of the Pathway Platform, keeping in mind that 
the number of patients with these measures in the pre- implementation patient group will be 
limited: 
• MDD remission: The proportion of patients with PHQ-9 <= 5 at the end of the study period. 
The last measurement available during the study period will be used to calculate remission.  
• MDD response: The proportion of patients with a 50% or greater reduction in PHQ-9 
scores. The first and last scores available during the study period will be used to calculate 
response.   
• Diagnosis progress notes stating change from mild, moderate, or sever, to in remission or 
partial remission will be assessed descriptively.  
 
Patient reported outcomes: The difference in scores between baseline, and 6-month follow up will 
be compared among patients using the Pathway Platform who completed the following measures: 
• PAM-13 
• CollaboRATE (this questionnaire is also included as a 3-month post-enrollment  
assessment and will be analyzed across all available time points) 
• WSAS 
 
8.3.3 Exploratory outcomes 
Patient clinical and reported outcomes: 
• The following patient reported outcomes will be collected in the Pathway Platform 
throughout the study. The difference in scores between the baseline measure, 6-months, 
and end of the studywill be compared. This will be restricted to patients who completed 
these scales at these two-time points. To be inclusive of all patients, additional analyses 
will be conducted to compare first and last scores available:  
o PHQ-9 
o WHO-5  
o PDQ-D5 

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• The following patient reported outcomes will be collected in the Pathway Platform and 
described at 6-months and end of the study: 
o Antidepressant Medication adherence  
o Antidepressant Medication dose adjustment and switches 
o Side effects 
o Depression remission  
o Depression response  
o Goal attainment 
• Patient reported outcomes (PAM-13, CollaboRATE and WSAS) will also be explored 
at 6 months and end of the study.  
Pathway Platform and report utilization: Pathway Platform analytics will be explored to 
understand patient adherence to the platform which includes frequency of logging into the Pathway 
Platform and frequency of completing each of the Pathway Platform functionalities. Care-team 
utilization of Pathway Platform reports will also be explored, including describing type of care 
team members who viewed the Pathway Platform reports as well as frequency of viewing the 
reports.  
Education utilization: Frequency of viewing material in the resource education center will be 
described by patient and by care-team members. Commonly viewed educational material will be 
highlighted.  
Subgroup analysis: primary, secondary, and exploratory outcomes will be compared across a 
number of patient demographic and clinical characteristics, including PHQ-9 severity at baseline, 
comorbidities (see appendix 3 for comorbid conditions and ICD codes), app utilization by patients, 
and EMR report utilization by providers. Additional subgroup analysis will be conducted by type 
of care model at the site level (e.g. collaborative care vs. non collaborative care sites).   
8.3.4 Patient and provider in-depth interviews  
In-depth interviews will be conducted at the end of the study period with approximately 20 patients 
and 15 care team members who have used the Pathway Platform. Interviews will involve 
discussing reactions and feedback on the Pathway Platform, education material, care team 
interface, and overall implementation of the Pathway Platform. These semi-instructed in-depth 
interviews will allow patients to reflect on the process and identify higher level causes behind any 
difficulties or challenges, explore any suggested changes and to gather general feedback regarding 
the participant’s experience during the study. Findings from this sub-study will complement the 
main study analysis and explore the use of the Pathway Platform App and what this could mean 
for ongoing development of the Pathway Platform. 

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8.3.5  System level performance  
Performance and patient outcomes evaluated in this study will be evaluated at the system level 
covering all primary care clinics. Data will be collected retrospectively on patients attending any 
primary care clinic during the study period. This data will be used to understand performance at 
the system level.  
8.4  Data analysis 
For primary and secondary hypothesis testing, process measures, patient clinical outcomes, and 
health care resource utilization will be compared pre- and post- implementation of the Pathway 
Platform.  
 
Additional patient reported outcomes will be compared among patients using the Pathway 
Platform only at baseline and end of study. For pre-implementation, outcomes will be assessed 
among patients who visited one of the study clinics at least once over the pre-implementation study 
period and were eligible to use the Pathway Platform, if it had been available. For the post-
implementation period, the Pathway Platform will be the data source for paired t-test analysis, 
assessing change in continuous variables including PHQ-9 scores. Categorical outcomes will be 
presented as proportions and compared using Pearson Chi2 test. Continuous outcomes will be 
assessed for normality and presented as means and standard deviations (SD) or medians and 
interquartile ranges (IQR); continuous outcomes will be compared using Student’s t test for 
independent groups. Two-tailed tests using a significance threshold of p < 0.05 will be used for all 
tests.  
Exploratory outcomes: will be described among patients attending the pathway platform clinics 
only and will be compared between baseline, 6-month  and extended follow up. Change in these 
outcomes overtime, including utilization analytics will also be explored. Categorical outcomes will 
be presented as proportions and compared using McNemars’ test. Continuous outcomes will be 
assessed for normality and presented as means and standard deviations (SD) or medians and 
interquartile ranges (IQR); continuous outcomes will be compared using Student’s Paired t test for 
single group comparison. Two-tailed tests using a significance threshold of p < 0.05 will be used 
for all tests. Goal attainment will be summarized by proportion of patients who achieve their 
identified goals based on the set time bound duration of the goal (i.e., GAS Score ≥50).29,30 The 
goal attainment scale adapted for depression yields a norm-based score (standardized to a mean of 
50, SD of 10) at baseline and at the end of the time bound goal; the change from score from baseline 
will also be summarized. 
System level performance: Process outcomes will be evaluated at the system level (all primary 

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care clinics) among patients fulfilling eligibility criteria, if the app were available. Descriptive 
analysis will be utilized to describe process outcomes across all clinics.  
In depth interviews: Interpretative Phenomenological Analysis will be used to analyze the 
qualitative data. To increase the rigor and validity of the analysis, and as a form of triangulation, 
the analysis will be conducted by 3 members of the research team (the lead qualitative researcher 
and 2 others). Analysis will involve 2 stages: (1) Data management, which will include, 
familiarization with the data, reading notes, and/or listening to the audio dialogue in order to 
extract main themes and ideas and thematic framework development, identifying the key issues 
and concepts present in the data and creating themes both inductively, based on the data, and 
deductively, based on the research questions, (2) Interpretation stage, which will include focused 
defining the main concepts and mapping the ways in which different parts of the data are related 
to each other.  
4. 
9.4  PARTICIPANT RIGHTS AND CONFIDENTIALITY  
4.1 9.4.1  Institutional Review Board (IRB) Review 
This protocol, the informed consent document, and any subsequent modifications will 
be reviewed and approved by the Advocate’s IRB, who is responsible for oversight of 
the study.   
4.2 9.4.2 Informed Consent Forms 
A signed consent form will be obtained from each participant by the Advocate Research 
Team. The consent form will describe the purpose of the study, the procedures to be 
followed, and the risks and benefits of participation. A copy will be given to each 
participant and will be documented in the participant’s record.  
4.3 9.4.3  Participant Confidentiality  
Data will be extracted from an EMR data pull as well as chart reviews and shared only 
with the clinic and research staff that are needed to identify eligible patients for the study 
in a password-protected MS Excel sheet.  For clinic staff, shared patient information will 
be limited to only the patients seen at that clinic location. All paper copies of study data 
collection forms will be stored in a secure location at Advocate Research Institute to 
maintain subject confidentiality.  
A subject ID will be assigned to each study participant; this will serve as a unique subject 
identifier for the study and Pathway Platform data. Data management for Pathway 
Platform data will have security processes in place that are service organizational control 

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or SOC2 compliant. This comprises data storage and transmission between the Pathway 
Platform, servers, and EMR system.  Data collected for the study will be maintained and 
monitored while the study is active and the identifying link will be destroyed upon study 
close. 
4.4 9.4.4Study Discontinuation  
The study may be discontinued at any time to ensure that research patients are protected.  
5. 
10.  TAKEDA MARKETED PRODUCT ADVERSE EVENT REPORTING 
REQUIREMENTS 
An AE is any untoward medical occurrence in a subject administered a Takeda medicinal product 
and which does not necessarily have to have a causal relationship with this treatment. An AE can 
therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, a new disease or worsening in severity or frequency of a concomitant disease, 
temporally associated with the use of a Takeda medicinal product, whether the event is considered 
causally related to the use of the Takeda product. 
10.1  Special Situation Reports and Product Quality Issues 
A special situation report (SSR) includes any of the following events:  
• Pregnancy: Any case in which a pregnant patient is exposed to a Takeda product or in 
which a female patient or female partner of a male patient becomes pregnant following 
treatment with Takeda product. Exposure is considered either through maternal exposure 
or via semen following paternal exposure. 
• Breastfeeding: Infant exposure from breast milk. 
• Overdose: All information of any accidental or intentional overdose. 
• Drug abuse, misuse or medication error: All information on medicinal product abuse, 
misuse or medication error (potential or actual). 
• Suspected transmission of an infectious agent: All information on a suspected (in the sense 
of confirmed or potential) transmission of an infectious agent by a medicinal product. 
• Lack of efficacy of Takeda product. 
• Occupational exposure. 
• Use outside the terms of the marketing authorization, also known as “off-label”. 
• Use of falsified medicinal product. 
A product quality issue refers to defects related to the safety, identity, strength, quality, or purity 
of the product or with the physical characteristics, packaging, labeling, or design of the product. 

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10.2  Procedures  
Collection and Reporting of Spontaneous AEs, SSRs, and Product Quality Issues Related to a 
Takeda Product: If during the conduct of the study, a health care professional or patient 
spontaneously reports an AE, SSR, or product quality issue where the event/issue pertains to a 
Takeda product (or unbranded generic); such information should be reported to the sponsor. As 
such reports are spontaneously notified, causality of any AEs should be assumed unless there is 
evidence to the contrary. 
AEs, SSRs or products complaints relating to any Takeda products received spontaneously must 
be reported via email or by telephone within 24 hours of awareness and no later than by the next 
working day. The preferred method for reporting is via email. If a report is received via telephone 
it should be backed up with an email. Advocate may submit Reportable Information to Takeda at 
medicalinformation@tpna.com. Alternatively, Advocate may submit Reportable Information to 
Takeda’s Call Center by calling 1-877-Takeda7. 
6. 
11.  PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this study will be governed by the policies and procedures developed 
by the Steering Committee, which will include representatives from Advocate Health Care and 
the Takeda/Lundbeck Alliance. Any presentation, abstract, or manuscript related to the data 
resulting from this study will be made available for review by Advocate Health Care and the 
Takeda/Lundbeck Alliance prior to submission. 
7. 
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2. Robotham D, Satkunanathan S, Doughty L, Wykes T. Do We Still Have a Digital Divide 
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7. Kroenke K, Spitzer RL and Williams JB. The PHQ-9: validity of a brief depression 
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8. Loh A, Simon D, Wills CE, Kriston L, Niebling W and Härter M. The effects of a shared 
decision-making intervention in primary care of depression: a cluster-randomized 
controlled trial. Patient Educ Couns. 2007;67:324-32. 
 
9. Hopwood M. The Shared Decision-Making Process in the Pharmacological Management 
of Depression. Patient. 2019.     
 
10. Von Korff M, Gruman J, Schaefer J, Curry SJ and Wagner EH. Collaborative 
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11. Katon  WRobinson  PVonKorff  MLin  EBush  TLudman  ESimon  GWalker  G A 
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Psychiatry. 1996;53924- 932 
 
12. Organization WH. Depression: A Global Public Health Concern. 2012. Accessed February 
28, 2019. 
 
13. McIntyre RS, Cha DS, Soczynska JK, et al. Cognitive deficits and functional outcomes in 
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14. Greenberg PE, Fournier AA, Sisitsky T, Pike CT, Kessler RC. The economic burden of 
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15. Kessler RC, Merikangas KR, Wang PS. The prevalence and correlates of workplace 
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16. Maggie McCue, Christopher Blair, Ben Fehnert, Francesca Cormack, Sara Sarkey, Anna 
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17. Lam R, Saragoussi D, Danchenko N, Lamy F, Rive B, Brevig T. Psychometric validation 
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François C.Adapting the Goal Attainment Approach for Major Depressive Disorder. 
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24. Forcino RC, Barr PJ, O'Malley AJ, et al. Using CollaboRATE, a brief patient-reported 
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States. Health Expect. 2018;21(1):82–89. doi:10.1111/hex.12588 
 
25.  Mundt JC, Marks IM, Shear MK, Greist JM. The Work and Social Adjustment Scale: a 
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26. Elwyn G, Edwards A, Wensing M, et al. Shared decision making: developing the 
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30. McCue M, Parikh SV, Mucha L, et al. Personalized Goal Attainment After a Switch to 
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Appendix 1: Selection criteria ICD codes 
Code Type 
Code 
Description 
ICD-9-CM DX 
296.26 
Major depressive disorder, single episode in full remission 
ICD-9-CM DX 
296.25 
Major depressive disorder, single episode, in partial or unspecified remission 
ICD-9-CM DX 
296.21 
Major depressive disorder, single episode, mild 
ICD-9-CM DX 
296.22 
Major depressive disorder, single episode, moderate 
ICD-9-CM DX 
296.24 
Major depressive disorder, single episode, severe, specified as with psychotic behavior 
ICD-9-CM DX 
296.23 
Major depressive disorder, single episode, severe, without mention of psychotic behavior 
ICD-9-CM DX 
296.20 
Major depressive disorder, single episode, unspecified 
ICD-9-CM DX 
296.36 
Major depressive disorder, recurrent episode, in full remission 
ICD-9-CM DX 
296.35 
Major depressive disorder, recurrent episode, in partial or unspecified remission 
ICD-9-CM DX 
296.31 
Major depressive disorder, recurrent episode, mild 
ICD-9-CM DX 
296.32 
Major depressive disorder, recurrent episode, moderate 
ICD-9-CM DX 
296.34 
Major depressive disorder, recurrent episode, severe, specified as with psychotic behavior 
ICD-9-CM DX 
296.33 
Major depressive disorder, recurrent episode, severe, without mention of psychotic behavior 
ICD-9-CM DX 
296.30 
Major depressive disorder, recurrent episode, unspecified 
ICD-9-CM DX 
296.x 
Manic depression/bipolar disorder (Episodic Mood Disorder) 
ICD-9-CM DX 
295.9x 
Schizophrenia 
ICD-10-CM DX 
F325 
Major depressive disorder, single episode, in full remission 
ICD-10-CM DX 
F324 
Major depressive disorder, single episode, in partial remission 
ICD-10-CM DX 
F320 
Major depressive disorder, single episode, mild 
ICD-10-CM DX 
F321 
Major depressive disorder, single episode, moderate 
ICD-10-CM DX 
F323 
Major depressive disorder, single episode, severe with psychotic features 
ICD-10-CM DX 
F322 
Major depressive disorder, single episode, severe without psychotic features 
ICD-10-CM DX 
F25.x 
Schizoaffective disorders 
ICD-10-CM DX 
F328 
Other specified depressive disorder 
ICD-10-CM DX 
F329 
Major depressive disorder, single episode, unspecified 
ICD-10-CM DX 
F332 
Major depressive disorder, recurrent severe without psychotic features 
ICD-10-CM DX 
F3342 
Major depressive disorder, recurrent, in full remission 
ICD-10-CM DX 
F3341 
Major depressive disorder, recurrent, in partial remission 
ICD-10-CM DX 
F3340 
Major depressive disorder, recurrent, in remission, unspecified 
ICD-10-CM DX 
F330 
Major depressive disorder, recurrent, mild 
ICD-10-CM DX 
F331 
Major depressive disorder, recurrent, moderate 
ICD-10-CM DX 
F333 
Major depressive disorder, recurrent, severe with psychotic symptoms 
ICD-10-CM DX 
F339 
Major depressive disorder, recurrent, unspecified 
ICD-10-CM DX 
F31.x 
Manic depression/bipolar disorder 
ICD-10-CM DX 
F20.x 
Schizophrenia 
ICD-10-CM DX 
F43.1 
Persistent depressive disorder 
ICD-10-CM DX 
F43.21 
Adjustment d/o with depressed mood  
ICD-10-CM DX 
F43.23 
Adjustment d/o with mixed anxiety and depressed mood  

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Appendix 2: List of antidepressant medication classes 
MEDICATION_ID 
NAME 
GENERIC_NAME 
ORDER_COUNT 
30792 
SERTRALINE HCL 50 MG PO TABS 
Sertraline HCl Tab 50 MG 
364265 
30791 
SERTRALINE HCL 100 MG PO TABS 
Sertraline HCl Tab 100 MG 
344586 
49150 
ESCITALOPRAM OXALATE 10 MG PO TABS 
Escitalopram Oxalate Tab 10 MG (Base Equiv) 
279295 
27521 
FLUOXETINE HCL 20 MG PO CAPS 
Fluoxetine HCl Cap 20 MG 
250226 
25473 
CITALOPRAM HYDROBROMIDE 20 MG PO TABS 
Citalopram Hydrobromide Tab 20 MG (Base Equiv) 
246662 
49151 
ESCITALOPRAM OXALATE 20 MG PO TABS 
Escitalopram Oxalate Tab 20 MG (Base Equiv) 
191759 
52482 
BUPROPION HCL ER (XL) 150 MG PO TB24 
Bupropion HCl Tab ER 24HR 150 MG 
191523 
54838 
DULOXETINE HCL 60 MG PO CPEP 
Duloxetine HCl Enteric Coated Pellets Cap 60 MG (Base 
Eq) 
179414 
41375 
VENLAFAXINE HCL ER 75 MG PO CP24 
Venlafaxine HCl Cap ER 24HR 75 MG (Base Equivalent) 
140523 
54837 
DULOXETINE HCL 30 MG PO CPEP 
Duloxetine HCl Enteric Coated Pellets Cap 30 MG (Base 
Eq) 
140369 
52483 
BUPROPION HCL ER (XL) 300 MG PO TB24 
Bupropion HCl Tab ER 24HR 300 MG 
136883 
41377 
VENLAFAXINE HCL ER 150 MG PO CP24 
Venlafaxine HCl Cap ER 24HR 150 MG (Base 
Equivalent) 
129493 
26233 
CITALOPRAM HYDROBROMIDE 40 MG PO TABS 
Citalopram Hydrobromide Tab 40 MG (Base Equiv) 
128087 
14668 
SERTRALINE HCL 25 MG PO TABS 
Sertraline HCl Tab 25 MG 
126081 
1130 
AMITRIPTYLINE HCL 25 MG PO TABS 
Amitriptyline HCl Tab 25 MG 
111075 
31120 
FLUOXETINE HCL 40 MG PO CAPS 
Fluoxetine HCl Cap 40 MG 
110799 
6802 
BUPROPION HCL ER (SR) 150 MG PO TB12 
Bupropion HCl Tab ER 12HR 150 MG 
110322 
3069 
MIRTAZAPINE 15 MG PO TABS 
Mirtazapine Tab 15 MG 
101445 
29473 
PAROXETINE HCL 20 MG PO TABS 
Paroxetine HCl Tab 20 MG 
93100 
45710 
CITALOPRAM HYDROBROMIDE 10 MG PO TABS 
Citalopram Hydrobromide Tab 10 MG (Base Equiv) 
88045 
1127 
AMITRIPTYLINE HCL 10 MG PO TABS 
Amitriptyline HCl Tab 10 MG 
84142 
27520 
FLUOXETINE HCL 10 MG PO CAPS 
Fluoxetine HCl Cap 10 MG 
76319 
41370 
VENLAFAXINE HCL ER 37.5 MG PO CP24 
Venlafaxine HCl Cap ER 24HR 37.5 MG (Base 
Equivalent) 
64038 
46525 
FLUOXETINE HCL 20 MG PO TABS 
Fluoxetine HCl Tab 20 MG 
47822 
43380 
PAROXETINE HCL 10 MG PO TABS 
Paroxetine HCl Tab 10 MG 
46591 
1131 
AMITRIPTYLINE HCL 50 MG PO TABS 
Amitriptyline HCl Tab 50 MG 
42808 
3068 
MIRTAZAPINE 30 MG PO TABS 
Mirtazapine Tab 30 MG 
41887 
43381 
PAROXETINE HCL 40 MG PO TABS 
Paroxetine HCl Tab 40 MG 
41484 
53289 
ESCITALOPRAM OXALATE 5 MG PO TABS 
Escitalopram Oxalate Tab 5 MG (Base Equiv) 
40429 
21941 
TRAZODONE HCL 150 MG PO TABS 
Trazodone HCl Tab 150 MG 
40137 
15185 
NORTRIPTYLINE HCL 10 MG PO CAPS 
Nortriptyline HCl Cap 10 MG 
38909 
33067 
VENLAFAXINE HCL 75 MG PO TABS 
Venlafaxine HCl Tab 75 MG (Base Equivalent) 
35559 
15186 
NORTRIPTYLINE HCL 25 MG PO CAPS 
Nortriptyline HCl Cap 25 MG 
33918 
54836 
DULOXETINE HCL 20 MG PO CPEP 
Duloxetine HCl Enteric Coated Pellets Cap 20 MG (Base 
Eq) 
33170 
49138 
LEXAPRO 10 MG PO TABS 
Escitalopram Oxalate Tab 10 MG (Base Equiv) 
25964 
29474 
PAROXETINE HCL 30 MG PO TABS 
Paroxetine HCl Tab 30 MG 
25543 
24234 
ZOLOFT 50 MG PO TABS 
Sertraline HCl Tab 50 MG 
24619 
6801 
BUPROPION HCL ER (SR) 100 MG PO TB12 
Bupropion HCl Tab ER 12HR 100 MG 
23869 
54049 
MIRTAZAPINE 7.5 MG PO TABS 
Mirtazapine Tab 7.5 MG 
23111 
30269 
FLUOXETINE HCL 10 MG PO TABS 
Fluoxetine HCl Tab 10 MG 
22273 

33 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
25491 
BUPROPION HCL 75 MG PO TABS 
Bupropion HCl Tab 75 MG 
21540 
33068 
VENLAFAXINE HCL 37.5 MG PO TABS 
Venlafaxine HCl Tab 37.5 MG (Base Equivalent) 
21070 
24233 
ZOLOFT 100 MG PO TABS 
Sertraline HCl Tab 100 MG 
20074 
16385 
PAXIL 20 MG PO TABS 
Paroxetine HCl Tab 20 MG 
18434 
25490 
BUPROPION HCL 100 MG PO TABS 
Bupropion HCl Tab 100 MG 
17921 
18059 
PROZAC 20 MG PO CAPS 
Fluoxetine HCl Cap 20 MG 
16426 
7035 
DOXEPIN HCL 10 MG PO CAPS 
Doxepin HCl Cap 10 MG 
16384 
1128 
AMITRIPTYLINE HCL 100 MG PO TABS 
Amitriptyline HCl Tab 100 MG 
16341 
72022 
DESVENLAFAXINE SUCCINATE ER 50 MG PO 
TB24 
Desvenlafaxine Succinate Tab ER 24HR 50 MG (Base 
Equiv) 
15946 
26237 
CELEXA 20 MG PO TABS 
Citalopram Hydrobromide Tab 20 MG (Base Equiv) 
15281 
15187 
NORTRIPTYLINE HCL 50 MG PO CAPS 
Nortriptyline HCl Cap 50 MG 
14927 
48727 
BUPROPION HCL ER (SR) 200 MG PO TB12 
Bupropion HCl Tab ER 12HR 200 MG 
14897 
20977 
EFFEXOR XR 75 MG PO CP24 
Venlafaxine HCl Cap ER 24HR 75 MG (Base Equivalent) 
14669 
29905 
MIRTAZAPINE 45 MG PO TABS 
Mirtazapine Tab 45 MG 
12852 
7038 
DOXEPIN HCL 25 MG PO CAPS 
Doxepin HCl Cap 25 MG 
12040 
49140 
LEXAPRO 20 MG PO TABS 
Escitalopram Oxalate Tab 20 MG (Base Equiv) 
10718 
54830 
CYMBALTA 60 MG PO CPEP 
Duloxetine HCl Enteric Coated Pellets Cap 60 MG (Base 
Eq) 
10331 
1132 
AMITRIPTYLINE HCL 75 MG PO TABS 
Amitriptyline HCl Tab 75 MG 
9606 
20979 
EFFEXOR XR 150 MG PO CP24 
Venlafaxine HCl Cap ER 24HR 150 MG (Base 
Equivalent) 
9586 
72023 
DESVENLAFAXINE SUCCINATE ER 100 MG PO 
TB24 
Desvenlafaxine Succinate Tab ER 24HR 100 MG (Base 
Equiv) 
9391 
6825 
WELLBUTRIN SR 150 MG PO TBCR 
NULL 
7725 
7039 
DOXEPIN HCL 50 MG PO CAPS 
Doxepin HCl Cap 50 MG 
7042 
52480 
WELLBUTRIN XL 150 MG PO TB24 
Bupropion HCl Tab ER 24HR 150 MG 
6968 
52481 
WELLBUTRIN XL 300 MG PO TB24 
Bupropion HCl Tab ER 24HR 300 MG 
6922 
80523 
VILAZODONE HCL 40 MG PO TABS 
Vilazodone HCl Tab 40 MG 
6849 
43371 
PAXIL 10 MG PO TABS 
Paroxetine HCl Tab 10 MG 
6813 
44901 
MIRTAZAPINE 15 MG PO TBDP 
Mirtazapine Orally Disintegrating Tab 15 MG 
6798 
10582 
IMIPRAMINE HCL 25 MG PO TABS 
Imipramine HCl Tab 25 MG 
6650 
74599 
VENLAFAXINE HCL ER 150 MG PO TB24 
Venlafaxine HCl Tab ER 24HR 150 MG (Base 
Equivalent) 
6585 
103956 
TRAZODONE HCL PO 
traZODone HCl 
6562 
54831 
CYMBALTA 30 MG PO CPEP 
Duloxetine HCl Enteric Coated Pellets Cap 30 MG (Base 
Eq) 
6485 
26238 
CELEXA 40 MG PO TABS 
Citalopram Hydrobromide Tab 40 MG (Base Equiv) 
6402 
27552 
FLUVOXAMINE MALEATE 100 MG PO TABS 
Fluvoxamine Maleate Tab 100 MG 
6244 
101719 
SERTRALINE HCL PO 
Sertraline HCl 
5893 
10583 
IMIPRAMINE HCL 50 MG PO TABS 
Imipramine HCl Tab 50 MG 
5647 
33064 
VENLAFAXINE HCL 25 MG PO TABS 
Venlafaxine HCl Tab 25 MG (Base Equivalent) 
5629 
33066 
VENLAFAXINE HCL 100 MG PO TABS 
Venlafaxine HCl Tab 100 MG (Base Equivalent) 
5403 
54119 
FLUOXETINE HCL 20 MG/5ML PO SOLN 
Fluoxetine HCl Solution 20 MG/5ML 
4766 
31386 
TRAZODONE HCL 300 MG PO TABS 
Trazodone HCl Tab 300 MG 
4706 
48243 
PAROXETINE HCL ER 25 MG PO TB24 
Paroxetine HCl Tab ER 24HR 25 MG 
4651 
74598 
VENLAFAXINE HCL ER 75 MG PO TB24 
Venlafaxine HCl Tab ER 24HR 75 MG (Base Equivalent) 
4581 

34 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
74600 
VENLAFAXINE HCL ER 225 MG PO TB24 
Venlafaxine HCl Tab ER 24HR 225 MG (Base 
Equivalent) 
4467 
6241 
DESIPRAMINE HCL 25 MG PO TABS 
Desipramine HCl Tab 25 MG 
4466 
27553 
FLUVOXAMINE MALEATE 50 MG PO TABS 
Fluvoxamine Maleate Tab 50 MG 
4418 
20976 
EFFEXOR XR 37.5 MG PO CP24 
Venlafaxine HCl Cap ER 24HR 37.5 MG (Base 
Equivalent) 
4403 
15188 
NORTRIPTYLINE HCL 75 MG PO CAPS 
Nortriptyline HCl Cap 75 MG 
4326 
52739 
WELLBUTRIN SR 150 MG PO TB12 
Bupropion HCl Tab ER 12HR 150 MG 
4203 
12168 
ZOLOFT 25 MG PO TABS 
Sertraline HCl Tab 25 MG 
4075 
18058 
PROZAC 10 MG PO CAPS 
Fluoxetine HCl Cap 10 MG 
3984 
91500 
FLUOXETINE HCL PO 
FLUoxetine HCl 
3908 
37510 
EFFEXOR 75 MG PO TABS 
Venlafaxine HCl Tab 75 MG (Base Equivalent) 
3893 
43372 
PAXIL 40 MG PO TABS 
Paroxetine HCl Tab 40 MG 
3812 
87235 
CITALOPRAM HYDROBROMIDE PO 
Citalopram Hydrobromide 
3777 
105378 
WELLBUTRIN PO 
buPROPion HCl 
3710 
16386 
PAXIL 30 MG PO TABS 
Paroxetine HCl Tab 30 MG 
3705 
121792 
VORTIOXETINE HBR 10 MG PO TABS 
Vortioxetine HBr Tab 10 MG (Base Equiv) 
3563 
32736 
PROZAC 40 MG PO CAPS 
Fluoxetine HCl Cap 40 MG 
3537 
107520 
FLUOXETINE HCL 60 MG PO TABS 
Fluoxetine HCl Tab 60 MG 
3446 
80522 
VILAZODONE HCL 20 MG PO TABS 
Vilazodone HCl Tab 20 MG 
3292 
105801 
ZOLOFT PO 
Sertraline HCl 
3283 
33065 
VENLAFAXINE HCL 50 MG PO TABS 
Venlafaxine HCl Tab 50 MG (Base Equivalent) 
3224 
37994 
SERTRALINE HCL 20 MG/ML PO CONC 
Sertraline HCl Oral Concentrate for Solution 20 MG/ML 
3209 
1129 
AMITRIPTYLINE HCL 150 MG PO TABS 
Amitriptyline HCl Tab 150 MG 
3202 
48254 
PAXIL CR 25 MG PO TB24 
Paroxetine HCl Tab ER 24HR 25 MG 
3169 
74597 
VENLAFAXINE HCL ER 37.5 MG PO TB24 
Venlafaxine HCl Tab ER 24HR 37.5 MG (Base 
Equivalent) 
3046 
94580 
LEXAPRO PO 
Escitalopram Oxalate 
2822 
44902 
MIRTAZAPINE 30 MG PO TBDP 
Mirtazapine Orally Disintegrating Tab 30 MG 
2795 
7036 
DOXEPIN HCL 100 MG PO CAPS 
Doxepin HCl Cap 100 MG 
2779 
10581 
IMIPRAMINE HCL 10 MG PO TABS 
Imipramine HCl Tab 10 MG 
2602 
121793 
VORTIOXETINE HBR 20 MG PO TABS 
Vortioxetine HBr Tab 20 MG (Base Equiv) 
2559 
84163 
AMITRIPTYLINE HCL PO 
Amitriptyline HCl 
2520 
48242 
PAROXETINE HCL ER 12.5 MG PO TB24 
Paroxetine HCl Tab ER 24HR 12.5 MG 
2485 
86048 
BUPROPION HCL PO 
buPROPion HCl 
2454 
48253 
PAXIL CR 12.5 MG PO TB24 
Paroxetine HCl Tab ER 24HR 12.5 MG 
2367 
88576 
CYMBALTA PO 
DULoxetine HCl 
2273 
4753 
CLOMIPRAMINE HCL 50 MG PO CAPS 
Clomipramine HCl Cap 50 MG 
2260 
99459 
PROZAC PO 
FLUoxetine HCl 
2168 
45716 
CELEXA 10 MG PO TABS 
Citalopram Hydrobromide Tab 10 MG (Base Equiv) 
2162 
48244 
PAROXETINE HCL ER 37.5 MG PO TB24 
Paroxetine HCl Tab ER 24HR 37.5 MG 
2150 
128150 
DESVENLAFAXINE SUCCINATE ER 25 MG PO 
TB24 
Desvenlafaxine Succinate Tab ER 24HR 25 MG (Base 
Equiv) 
1978 
115687 
BUPROPION HCL ER (XL) 450 MG PO TB24 
Bupropion HCl Tab ER 24HR 450 MG 
1965 
72176 
PRISTIQ 50 MG PO TB24 
Desvenlafaxine Succinate Tab ER 24HR 50 MG (Base 
Equiv) 
1951 
37511 
EFFEXOR 37.5 MG PO TABS 
Venlafaxine HCl Tab 37.5 MG (Base Equivalent) 
1899 

35 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
128921 
DULOXETINE HCL 40 MG PO CPEP 
Duloxetine HCl Enteric Coated Pellets Cap 40 MG (Base 
Eq) 
1710 
44894 
REMERON SOLTAB 30 MG PO TBDP 
Mirtazapine Orally Disintegrating Tab 30 MG 
1696 
26357 
CLOMIPRAMINE HCL 25 MG PO CAPS 
Clomipramine HCl Cap 25 MG 
1674 
6242 
DESIPRAMINE HCL 50 MG PO TABS 
Desipramine HCl Tab 50 MG 
1638 
3093 
REMERON 15 MG PO TABS 
Mirtazapine Tab 15 MG 
1593 
80521 
VILAZODONE HCL 10 MG PO TABS 
Vilazodone HCl Tab 10 MG 
1563 
44893 
REMERON SOLTAB 15 MG PO TBDP 
Mirtazapine Orally Disintegrating Tab 15 MG 
1518 
7491 
ELAVIL 25 MG PO TABS 
Amitriptyline HCl Tab 25 MG 
1500 
7488 
ELAVIL 10 MG PO TABS 
Amitriptyline HCl Tab 10 MG 
1450 
7040 
DOXEPIN HCL 75 MG PO CAPS 
Doxepin HCl Cap 75 MG 
1436 
3094 
REMERON 30 MG PO TABS 
Mirtazapine Tab 30 MG 
1391 
6823 
WELLBUTRIN SR 100 MG PO TBCR 
NULL 
1388 
6238 
DESIPRAMINE HCL 10 MG PO TABS 
Desipramine HCl Tab 10 MG 
1360 
72177 
PRISTIQ 100 MG PO TB24 
Desvenlafaxine Succinate Tab ER 24HR 100 MG (Base 
Equiv) 
1336 
54829 
CYMBALTA 20 MG PO CPEP 
Duloxetine HCl Enteric Coated Pellets Cap 20 MG (Base 
Eq) 
1308 
90158 
EFFEXOR PO 
Venlafaxine HCl 
1307 
23872 
WELLBUTRIN 100 MG PO TABS 
Bupropion HCl Tab 100 MG 
1266 
104831 
VENLAFAXINE HCL PO 
Venlafaxine HCl 
1255 
53337 
LEXAPRO 5 MG PO TABS 
Escitalopram Oxalate Tab 5 MG (Base Equiv) 
1189 
80922 
VIIBRYD 40 MG PO TABS 
Vilazodone HCl Tab 40 MG 
1167 
36044 
NEFAZODONE HCL 100 MG PO TABS 
Nefazodone HCl Tab 100 MG 
1121 
122218 
LEVOMILNACIPRAN HCL ER 40 MG PO CP24 
Levomilnacipran HCl Cap ER 24HR 40 MG (Base 
Equivalent) 
1079 
90794 
ESCITALOPRAM OXALATE PO 
Escitalopram Oxalate 
1059 
38018 
CITALOPRAM HYDROBROMIDE 10 MG/5ML PO 
SOLN 
Citalopram Hydrobromide Oral Soln 10 MG/5ML 
1041 
50590 
ESCITALOPRAM OXALATE 5 MG/5ML PO SOLN 
Escitalopram Oxalate Soln 5 MG/5ML (Base Equiv) 
1022 
36046 
NEFAZODONE HCL 200 MG PO TABS 
Nefazodone HCl Tab 200 MG 
982 
36045 
NEFAZODONE HCL 150 MG PO TABS 
Nefazodone HCl Tab 150 MG 
977 
17917 
FLUVOXAMINE MALEATE 25 MG PO TABS 
Fluvoxamine Maleate Tab 25 MG 
965 
89706 
DULOXETINE HCL PO 
DULoxetine HCl 
940 
7037 
DOXEPIN HCL 150 MG PO CAPS 
Doxepin HCl Cap 150 MG 
929 
97999 
PAXIL PO 
PARoxetine HCl 
913 
26358 
CLOMIPRAMINE HCL 75 MG PO CAPS 
Clomipramine HCl Cap 75 MG 
911 
23873 
WELLBUTRIN 75 MG PO TABS 
Bupropion HCl Tab 75 MG 
875 
30321 
PROTRIPTYLINE HCL 5 MG PO TABS 
Protriptyline HCl Tab 5 MG 
860 
97988 
PAROXETINE HCL PO 
PARoxetine HCl 
852 
38229 
SERZONE 150 MG PO TABS 
Nefazodone HCl Tab 150 MG 
837 
30320 
PROTRIPTYLINE HCL 10 MG PO TABS 
Protriptyline HCl Tab 10 MG 
828 
95905 
MIRTAZAPINE PO 
Mirtazapine 
820 
121791 
VORTIOXETINE HBR 5 MG PO TABS 
Vortioxetine HBr Tab 5 MG (Base Equiv) 
817 
52738 
WELLBUTRIN SR 100 MG PO TB12 
Bupropion HCl Tab ER 12HR 100 MG 
804 
72073 
FLUVOXAMINE MALEATE ER 100 MG PO CP24 
Fluvoxamine Maleate Cap ER 24HR 100 MG 
764 

36 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
122219 
LEVOMILNACIPRAN HCL ER 80 MG PO CP24 
Levomilnacipran HCl Cap ER 24HR 80 MG (Base 
Equivalent) 
764 
86679 
CELEXA PO 
Citalopram Hydrobromide 
752 
48255 
PAXIL CR 37.5 MG PO TB24 
Paroxetine HCl Tab ER 24HR 37.5 MG 
740 
52740 
WELLBUTRIN SR 200 MG PO TB12 
Bupropion HCl Tab ER 12HR 200 MG 
712 
45394 
MIRTAZAPINE 45 MG PO TBDP 
Mirtazapine Orally Disintegrating Tab 45 MG 
695 
38228 
SERZONE 200 MG PO TABS 
Nefazodone HCl Tab 200 MG 
661 
45212 
PROZAC WEEKLY 90 MG PO CPDR 
Fluoxetine HCl Cap Delayed Release 90 MG 
653 
90159 
EFFEXOR XR PO 
Venlafaxine HCl 
653 
113119 
VILAZODONE HCL 10 & 20 & 40 MG PO KIT 
Vilazodone HCl Tab Starter Kit 10 (7) & 20 (7) & 40 (16) 
MG 
620 
122220 
LEVOMILNACIPRAN HCL ER 120 MG PO CP24 
Levomilnacipran HCl Cap ER 24HR 120 MG (Base 
Equivalent) 
596 
38227 
SERZONE 100 MG PO TABS 
Nefazodone HCl Tab 100 MG 
589 
45213 
FLUOXETINE HCL 90 MG PO CPDR 
Fluoxetine HCl Cap Delayed Release 90 MG 
561 
72074 
FLUVOXAMINE MALEATE ER 150 MG PO CP24 
Fluvoxamine Maleate Cap ER 24HR 150 MG 
553 
122217 
LEVOMILNACIPRAN HCL ER 20 MG PO CP24 
Levomilnacipran HCl Cap ER 24HR 20 MG (Base 
Equivalent) 
547 
29910 
REMERON 45 MG PO TABS 
Mirtazapine Tab 45 MG 
526 
6239 
DESIPRAMINE HCL 100 MG PO TABS 
Desipramine HCl Tab 100 MG 
510 
7041 
DOXEPIN HCL 10 MG/ML PO CONC 
Doxepin HCl Conc 10 MG/ML 
495 
29648 
PHENELZINE SULFATE 15 MG PO TABS 
Phenelzine Sulfate Tab 15 MG 
487 
7492 
ELAVIL 50 MG PO TABS 
Amitriptyline HCl Tab 50 MG 
469 
119146 
DESVENLAFAXINE ER 50 MG PO TB24 
Desvenlafaxine Tab ER 24HR 50 MG 
465 
97070 
NORTRIPTYLINE HCL PO 
Nortriptyline HCl 
439 
82218 
TRAZODONE HCL ER 150 MG PO TB24 
Trazodone HCl Tab ER 24HR 150 MG 
431 
37509 
EFFEXOR 100 MG PO TABS 
Venlafaxine HCl Tab 100 MG (Base Equivalent) 
430 
29178 
NORTRIPTYLINE HCL 10 MG/5ML PO SOLN 
Nortriptyline HCl Soln 10 MG/5ML 
410 
99177 
PRISTIQ PO 
Desvenlafaxine Succinate 
404 
24605 
PAROXETINE HCL 10 MG/5ML PO SUSP 
Paroxetine HCl Oral Susp 10 MG/5ML (Base Equiv) 
401 
48739 
WELLBUTRIN SR 200 MG PO TBCR 
NULL 
379 
132523 
TRINTELLIX 20 MG PO TABS 
Vortioxetine HBr Tab 20 MG (Base Equiv) 
361 
30290 
PROZAC 10 MG PO TABS 
Fluoxetine HCl Tab 10 MG 
358 
105380 
WELLBUTRIN XL PO 
buPROPion HCl 
343 
80921 
VIIBRYD 20 MG PO TABS 
Vilazodone HCl Tab 20 MG 
338 
6243 
DESIPRAMINE HCL 75 MG PO TABS 
Desipramine HCl Tab 75 MG 
337 
100750 
REMERON PO 
Mirtazapine 
336 
132522 
TRINTELLIX 10 MG PO TABS 
Vortioxetine HBr Tab 10 MG (Base Equiv) 
324 
37507 
EFFEXOR 25 MG PO TABS 
Venlafaxine HCl Tab 25 MG (Base Equivalent) 
311 
119147 
DESVENLAFAXINE ER 100 MG PO TB24 
Desvenlafaxine Tab ER 24HR 100 MG 
283 
19392 
NEFAZODONE HCL 50 MG PO TABS 
Nefazodone HCl Tab 50 MG 
269 
82549 
VIIBRYD PO 
Vilazodone HCl 
266 
53826 
BUDEPRION SR 150 MG PO TB12 
Bupropion HCl Tab ER 12HR 150 MG 
263 
37508 
EFFEXOR 50 MG PO TABS 
Venlafaxine HCl Tab 50 MG (Base Equivalent) 
258 
27929 
IMIPRAMINE PAMOATE 75 MG PO CAPS 
Imipramine Pamoate Cap 75 MG 
245 
27926 
IMIPRAMINE PAMOATE 100 MG PO CAPS 
Imipramine Pamoate Cap 100 MG 
238 

37 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
23796 
VIVACTIL 10 MG PO TABS 
Protriptyline HCl Tab 10 MG 
235 
1156 
AMOXAPINE 50 MG PO TABS 
Amoxapine Tab 50 MG 
235 
37925 
LUVOX 100 MG PO TABS 
Fluvoxamine Maleate Tab 100 MG 
228 
16153 
PAMELOR 10 MG PO CAPS 
Nortriptyline HCl Cap 10 MG 
226 
89586 
DOXEPIN HCL PO 
Doxepin HCl 
225 
53112 
PAROXETINE MESYLATE 20 MG PO TABS 
Paroxetine Mesylate Tab 20 MG (Base Equiv) 
221 
31385 
TRANYLCYPROMINE SULFATE 10 MG PO TABS 
Tranylcypromine Sulfate Tab 10 MG 
216 
129677 
VILAZODONE HCL 10 & 20 MG PO KIT 
Vilazodone HCl Tab Starter Kit 10 (7) & 20 (23) MG 
203 
7493 
ELAVIL 75 MG PO TABS 
Amitriptyline HCl Tab 75 MG 
197 
1153 
AMOXAPINE 100 MG PO TABS 
Amoxapine Tab 100 MG 
195 
61428 
BUDEPRION XL 300 MG PO TB24 
Bupropion HCl Tab ER 24HR 300 MG 
192 
122246 
LEVOMILNACIPRAN HCL ER 20 & 40 MG PO 
C4PK 
Levomilnacipran HCl Cap ER 24HR 20 & 40 MG 
Therapy Pack 
192 
19852 
SERZONE 50 MG PO TABS 
Nefazodone HCl Tab 50 MG 
183 
1155 
AMOXAPINE 25 MG PO TABS 
Amoxapine Tab 25 MG 
183 
72990 
BUDEPRION XL 150 MG PO TB24 
Bupropion HCl Tab ER 24HR 150 MG 
181 
59776 
SELEGILINE 6 MG/24HR TD PT24 
Selegiline TD Patch 24HR 6 MG/24HR 
175 
38259 
NEFAZODONE HCL 250 MG PO TABS 
Nefazodone HCl Tab 250 MG 
157 
16154 
PAMELOR 25 MG PO CAPS 
Nortriptyline HCl Cap 25 MG 
156 
37926 
LUVOX 50 MG PO TABS 
Fluvoxamine Maleate Tab 50 MG 
150 
7489 
ELAVIL 100 MG PO TABS 
Amitriptyline HCl Tab 100 MG 
146 
103953 
TRAZAMINE PO 
NULL 
143 
132712 
TRINTELLIX PO 
Vortioxetine HBr 
141 
122242 
FETZIMA 80 MG PO CP24 
Levomilnacipran HCl Cap ER 24HR 80 MG (Base 
Equivalent) 
138 
12816 
MAPROTILINE HCL 50 MG PO TABS 
Maprotiline HCl Tab 50 MG 
138 
27928 
IMIPRAMINE PAMOATE 150 MG PO CAPS 
Imipramine Pamoate Cap 150 MG 
134 
6240 
DESIPRAMINE HCL 150 MG PO TABS 
Desipramine HCl Tab 150 MG 
134 
80920 
VIIBRYD 10 MG PO TABS 
Vilazodone HCl Tab 10 MG 
126 
53114 
PAROXETINE MESYLATE 40 MG PO TABS 
Paroxetine Mesylate Tab 40 MG (Base Equiv) 
124 
24603 
PAXIL 10 MG/5ML PO SUSP 
Paroxetine HCl Oral Susp 10 MG/5ML (Base Equiv) 
122 
115898 
FORFIVO XL 450 MG PO TB24 
Bupropion HCl Tab ER 24HR 450 MG 
122 
45380 
REMERON SOLTAB 45 MG PO TBDP 
Mirtazapine Orally Disintegrating Tab 45 MG 
117 
53111 
PAROXETINE MESYLATE 10 MG PO TABS 
Paroxetine Mesylate Tab 10 MG (Base Equiv) 
117 
1230 
ANAFRANIL 50 MG PO CAPS 
Clomipramine HCl Cap 50 MG 
112 
122245 
FETZIMA 40 MG PO CP24 
Levomilnacipran HCl Cap ER 24HR 40 MG (Base 
Equivalent) 
109 
12815 
MAPROTILINE HCL 25 MG PO TABS 
Maprotiline HCl Tab 25 MG 
106 
16155 
PAMELOR 50 MG PO CAPS 
Nortriptyline HCl Cap 50 MG 
105 
59778 
SELEGILINE 12 MG/24HR TD PT24 
Selegiline TD Patch 24HR 12 MG/24HR 
103 
116927 
BUPROPION HBR ER PO 
buPROPion HBr 
99 
97071 
NORTRIPYTLINE HCL PO 
Nortriptyline HCl 
93 
122243 
FETZIMA 120 MG PO CP24 
Levomilnacipran HCl Cap ER 24HR 120 MG (Base 
Equivalent) 
92 
105379 
WELLBUTRIN SR PO 
buPROPion HCl 
89 
38230 
SERZONE 250 MG PO TABS 
Nefazodone HCl Tab 250 MG 
86 

38 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
14441 
NARDIL 15 MG PO TABS 
Phenelzine Sulfate Tab 15 MG 
82 
117245 
VENLAFAXINE HCL ER PO 
Venlafaxine HCl 
82 
86043 
BUPROPION HBR PO 
buPROPion HBr 
80 
20758 
SURMONTIL 50 MG PO CAPS 
Trimipramine Maleate Cap 50 MG 
78 
38025 
CELEXA 10 MG/5ML PO SOLN 
Citalopram Hydrobromide Oral Soln 10 MG/5ML 
78 
37993 
ZOLOFT 20 MG/ML PO CONC 
Sertraline HCl Oral Concentrate for Solution 20 MG/ML 
74 
116013 
BUPROPION HCL ER (SR) PO 
buPROPion HCl 
74 
53113 
PAROXETINE MESYLATE 30 MG PO TABS 
Paroxetine Mesylate Tab 30 MG (Base Equiv) 
73 
53251 
PEXEVA 20 MG PO TABS 
Paroxetine Mesylate Tab 20 MG (Base Equiv) 
71 
59777 
SELEGILINE 9 MG/24HR TD PT24 
Selegiline TD Patch 24HR 9 MG/24HR 
70 
1229 
ANAFRANIL 25 MG PO CAPS 
Clomipramine HCl Cap 25 MG 
69 
21746 
TOFRANIL 25 MG PO TABS 
Imipramine HCl Tab 25 MG 
69 
75930 
BUPROPION HBR ER 522 MG PO TB24 
Bupropion HBr Tab ER 24HR 522 MG 
66 
82219 
TRAZODONE HCL ER 300 MG PO TB24 
Trazodone HCl Tab ER 24HR 300 MG 
66 
93521 
IMIPRAMINE HCL PO 
Imipramine HCl 
64 
132521 
TRINTELLIX 5 MG PO TABS 
Vortioxetine HBr Tab 5 MG (Base Equiv) 
63 
122496 
FETZIMA PO 
Levomilnacipran HCl 
61 
116014 
BUPROPION HCL ER (XL) PO 
buPROPion HCl 
60 
21747 
TOFRANIL 50 MG PO TABS 
Imipramine HCl Tab 50 MG 
58 
400628 
VENLAFAXINE(COMPOUNDED) 15 MG/ML PO 
SUSP 
venlafaxine (compounded) 15 mg/mL po susp 
57 
117239 
TRAZODONE HCL ER PO 
traZODone HCl 
55 
6271 
DESYREL 150 MG PO TABS 
Trazodone HCl Tab 150 MG 
54 
1154 
AMOXAPINE 150 MG PO TABS 
Amoxapine Tab 150 MG 
53 
15182 
NORPRAMIN 25 MG PO TABS 
Desipramine HCl Tab 25 MG 
53 
95046 
LUVOX CR PO 
fluvoxaMINE Maleate 
53 
12817 
MAPROTILINE HCL 75 MG PO TABS 
Maprotiline HCl Tab 75 MG 
51 
55184 
PROZAC 20 MG/5ML PO SOLN 
Fluoxetine HCl Solution 20 MG/5ML 
49 
75223 
CITALOPRAM & DIET MANAGE PROD 10 MG PO 
MISC 
Citalopram Tab 10 MG & Dietary Management Cap Pack 
47 
32005 
NORTRIPYTLINE HCL 25 MG PO CAPS 
Nortriptyline HCl Cap 25 MG 
47 
121979 
BRINTELLIX PO 
Vortioxetine HBr 
46 
87415 
CLOMIPRAMINE HCL PO 
clomiPRAMINE HCl 
46 
128151 
PRISTIQ 25 MG PO TB24 
Desvenlafaxine Succinate Tab ER 24HR 25 MG (Base 
Equiv) 
45 
72075 
LUVOX CR 100 MG PO CP24 
Fluvoxamine Maleate Cap ER 24HR 100 MG 
45 
15737 
LUVOX 25 MG PO TABS 
Fluvoxamine Maleate Tab 25 MG 
43 
91526 
FLUVOXAMINE MALEATE PO 
fluvoxaMINE Maleate 
43 
122244 
FETZIMA 20 MG PO CP24 
Levomilnacipran HCl Cap ER 24HR 20 MG (Base 
Equivalent) 
42 
76881 
BUPROPION HBR ER 174 MG PO TB24 
Bupropion HBr Tab ER 24HR 174 MG 
41 
6272 
DESYREL 300 MG PO TABS 
Trazodone HCl Tab 300 MG 
41 
18060 
PROZAC 20 MG/5ML PO LIQD 
NULL 
38 
132397 
ELAVIL PO 
Amitriptyline HCl 
37 
123813 
DESVENLAFAXINE FUMARATE ER 50 MG PO 
TB24 
Desvenlafaxine Fumarate Tab ER 24HR 50 MG (Base 
Equiv) 
33 
27522 
FLUOXETINE HCL 20 MG/5ML PO LIQD 
NULL 
33 

39 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
2057 
TRAZODONE HCL POWD 
Trazodone HCl Powder 
33 
1126 
AMITRIPTYLINE HCL 10 MG/ML IM SOLN 
NULL 
33 
75929 
BUPROPION HBR ER 348 MG PO TB24 
Bupropion HBr Tab ER 24HR 348 MG 
32 
22238 
TRIMIPRAMINE MALEATE 25 MG PO CAPS 
Trimipramine Maleate Cap 25 MG 
32 
22239 
TRIMIPRAMINE MALEATE 50 MG PO CAPS 
Trimipramine Maleate Cap 50 MG 
32 
16156 
PAMELOR 75 MG PO CAPS 
Nortriptyline HCl Cap 75 MG 
32 
7490 
ELAVIL 150 MG PO TABS 
Amitriptyline HCl Tab 150 MG 
32 
72076 
LUVOX CR 150 MG PO CP24 
Fluvoxamine Maleate Cap ER 24HR 150 MG 
31 
22237 
TRIMIPRAMINE MALEATE 100 MG PO CAPS 
Trimipramine Maleate Cap 100 MG 
30 
19544 
SINEQUAN 50 MG PO CAPS 
Doxepin HCl Cap 50 MG 
29 
50589 
LEXAPRO 5 MG/5ML PO SOLN 
Escitalopram Oxalate Soln 5 MG/5ML (Base Equiv) 
29 
119271 
DESVENLAFAXINE ER PO 
Desvenlafaxine 
27 
27927 
IMIPRAMINE PAMOATE 125 MG PO CAPS 
Imipramine Pamoate Cap 125 MG 
27 
121840 
BRINTELLIX 10 MG PO TABS 
Vortioxetine HBr Tab 10 MG (Base Equiv) 
27 
121841 
BRINTELLIX 20 MG PO TABS 
Vortioxetine HBr Tab 20 MG (Base Equiv) 
27 
96617 
NEFAZODONE HCL PO 
Nefazodone HCl 
26 
53253 
PEXEVA 40 MG PO TABS 
Paroxetine Mesylate Tab 40 MG (Base Equiv) 
26 
82550 
VILAZODONE HCL PO 
Vilazodone HCl 
26 
19545 
SINEQUAN 75 MG PO CAPS 
Doxepin HCl Cap 75 MG 
25 
97998 
PAXIL CR PO 
PARoxetine HCl 
24 
23797 
VIVACTIL 5 MG PO TABS 
Protriptyline HCl Tab 5 MG 
22 
89055 
DESYREL PO 
traZODone HCl 
21 
97989 
PAROXETINE MESYLATE PO 
PARoxetine Mesylate 
20 
53633 
BUDEPRION SR 100 MG PO TB12 
Bupropion HCl Tab ER 12HR 100 MG 
20 
53252 
PEXEVA 30 MG PO TABS 
Paroxetine Mesylate Tab 30 MG (Base Equiv) 
19 
59804 
EMSAM 6 MG/24HR TD PT24 
Selegiline TD Patch 24HR 6 MG/24HR 
19 
89011 
DESIPRAMINE HCL PO 
Desipramine HCl 
19 
113548 
VIIBRYD 10 & 20 & 40 MG PO KIT 
Vilazodone HCl Tab Starter Kit 10 (7) & 20 (7) & 40 (16) 
MG 
19 
84224 
ANAFRANIL PO 
clomiPRAMINE HCl 
18 
76061 
APLENZIN 522 MG PO TB24 
Bupropion HBr Tab ER 24HR 522 MG 
18 
20756 
SURMONTIL 100 MG PO CAPS 
Trimipramine Maleate Cap 100 MG 
18 
20757 
SURMONTIL 25 MG PO CAPS 
Trimipramine Maleate Cap 25 MG 
17 
53250 
PEXEVA 10 MG PO TABS 
Paroxetine Mesylate Tab 10 MG (Base Equiv) 
17 
123815 
DESVENLAFAXINE FUMARATE ER 100 MG PO 
TB24 
Desvenlafaxine Fumarate Tab ER 24HR 100 MG (Base 
Equiv) 
17 
99446 
PROTRIPTYLINE HCL PO 
Protriptyline HCl 
17 
116975 
DESVENLAFAXINE SUCCINATE ER PO 
Desvenlafaxine Succinate 
16 
97884 
PAMELOR PO 
Nortriptyline HCl 
15 
1231 
ANAFRANIL 75 MG PO CAPS 
Clomipramine HCl Cap 75 MG 
15 
21751 
TOFRANIL-PM 75 MG PO CAPS 
Imipramine Pamoate Cap 75 MG 
15 
122259 
FETZIMA TITRATION 20 & 40 MG PO C4PK 
Levomilnacipran HCl Cap ER 24HR 20 & 40 MG 
Therapy Pack 
14 
16338 
PARNATE 10 MG PO TABS 
Tranylcypromine Sulfate Tab 10 MG 
14 
129681 
VIIBRYD STARTER PACK 10 & 20 MG PO KIT 
Vilazodone HCl Tab Starter Kit 10 (7) & 20 (23) MG 
14 

40 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
87234 
CITALOPRAM & DIET MANAGE PROD PO 
NULL 
12 
19541 
SINEQUAN 100 MG PO CAPS 
Doxepin HCl Cap 100 MG 
12 
59874 
EMSAM 12 MG/24HR TD PT24 
Selegiline TD Patch 24HR 12 MG/24HR 
11 
103954 
TRAZODONE & DIET MANAGE PROD PO 
NULL 
10 
76060 
APLENZIN 348 MG PO TB24 
Bupropion HBr Tab ER 24HR 348 MG 
10 
15183 
NORPRAMIN 50 MG PO TABS 
Desipramine HCl Tab 50 MG 
10 
15179 
NORPRAMIN 10 MG PO TABS 
Desipramine HCl Tab 10 MG 
10 
19543 
SINEQUAN 25 MG PO CAPS 
Doxepin HCl Cap 25 MG 
10 
84189 
AMOXAPINE PO 
Amoxapine 
9 
21745 
TOFRANIL 10 MG PO TABS 
Imipramine HCl Tab 10 MG 
8 
96477 
NARDIL PO 
Phenelzine Sulfate 
8 
68121 
FLUOXETINE & DIET MANAGE PROD 10 MG PO 
MISC 
Fluoxetine HCl Cap 10 MG & Dietary Management Cap 
Pack 
8 
59871 
EMSAM 9 MG/24HR TD PT24 
Selegiline TD Patch 24HR 9 MG/24HR 
7 
1891 
ASENDIN TABS 50 MG PO 
Amoxapine Tab 50 MG 
7 
98330 
PEXEVA PO 
PARoxetine Mesylate 
7 
19540 
SINEQUAN 10 MG PO CAPS 
Doxepin HCl Cap 10 MG 
7 
108627 
BUPROPION HCL (XL) PO 
buPROPion HCl 
7 
117143 
PAROXETINE HCL ER PO 
PARoxetine HCl 
6 
108626 
BUPROPION HCL (SR) PO 
buPROPion HCl 
6 
15180 
NORPRAMIN 100 MG PO TABS 
Desipramine HCl Tab 100 MG 
6 
7487 
ELAVIL 10 MG/ML IM SOLN 
NULL 
6 
27338 
ISOCARBOXAZID 10 MG PO TABS 
Isocarboxazid Tab 10 MG 
6 
97986 
PARNATE PO 
Tranylcypromine Sulfate 
5 
85979 
BUDEPRION XL PO 
buPROPion HCl 
5 
85978 
BUDEPRION SR PO 
buPROPion HCl 
5 
75165 
AMITRIPTYLINE & DIET MANAGE PR 25 MG PO 
MISC 
Amitriptyline HCl Tab 25 MG & Diet Manage Prod Cap 
Pack 
5 
105240 
VIVACTIL PO 
Protriptyline HCl 
5 
84461 
APLENZIN PO 
buPROPion HBr 
5 
122087 
VORTIOXETINE HBR PO 
Vortioxetine HBr 
5 
99460 
PROZAC WEEKLY PO 
FLUoxetine HCl 
4 
130049 
VIIBRYD STARTER PACK PO 
Vilazodone HCl 
4 
103824 
TOFRANIL PO 
Imipramine HCl 
4 
117032 
FLUVOXAMINE MALEATE ER PO 
fluvoxaMINE Maleate 
4 
21750 
TOFRANIL-PM 150 MG PO CAPS 
Imipramine Pamoate Cap 150 MG 
4 
98385 
PHENELZINE SULFATE PO 
Phenelzine Sulfate 
4 
16157 
PAMELOR 10 MG/5ML PO SOLN 
Nortriptyline HCl Soln 10 MG/5ML 
4 
19542 
SINEQUAN 150 MG PO CAPS 
Doxepin HCl Cap 150 MG 
3 
21749 
TOFRANIL-PM 125 MG PO CAPS 
Imipramine Pamoate Cap 125 MG 
3 
104125 
TRIMIPRAMINE MALEATE PO 
Trimipramine Maleate 
3 
97063 
NORPRAMIN PO 
Desipramine HCl 
3 
103921 
TRANYLCYPROMINE SULFATE PO 
Tranylcypromine Sulfate 
3 
2099 
NORTRIPTYLINE HCL POWD 
Nortriptyline HCl Powder 
3 

41 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
148925 
ESKETAMINE HCL (56 MG DOSE) 28 MG/DEVICE 
NA SOPK 
Esketamine HCl Nasal Soln 28 MG/Device x 2 (56 MG 
Dose Pack) 
3 
100571 
RAPIFLUX PO 
FLUoxetine HCl 
3 
86042 
BUPROPION & DIET MANAGE PROD PO 
NULL 
3 
91770 
GABOXETINE PO 
NULL 
3 
91498 
FLUOXETINE & DIET MANAGE PROD PO 
NULL 
3 
90276 
EMSAM TD 
Selegiline 
2 
82404 
OLEPTRO 300 MG PO TB24 
Trazodone HCl Tab ER 24HR 300 MG 
2 
82403 
OLEPTRO 150 MG PO TB24 
Trazodone HCl Tab ER 24HR 150 MG 
2 
100751 
REMERON SOLTAB PO 
Mirtazapine 
2 
93522 
IMIPRAMINE PAMOATE PO 
Imipramine Pamoate 
2 
95225 
MAPROTILINE HCL PO 
Maprotiline HCl 
2 
121507 
KHEDEZLA PO 
Desvenlafaxine 
2 
148927 
ESKETAMINE HCL (84 MG DOSE) 28 MG/DEVICE 
NA SOPK 
Esketamine HCl Nasal Soln 28 MG/Device x 3 (84 MG 
Dose Pack) 
2 
1881 
IMIPRAMINE HCL POWD 
Imipramine HCl Powder 
2 
68122 
GABOXETINE 10 MG PO MISC 
Fluoxetine HCl Cap 10 MG & Dietary Management Cap 
Pack 
2 
21748 
TOFRANIL-PM 100 MG PO CAPS 
Imipramine Pamoate Cap 100 MG 
2 
27248 
MARPLAN 10 MG PO TABS 
Isocarboxazid Tab 10 MG 
2 
15181 
NORPRAMIN 150 MG PO TABS 
Desipramine HCl Tab 150 MG 
1 
103825 
TOFRANIL-PM PO 
Imipramine Pamoate 
1 
116112 
FORFIVO XL PO 
buPROPion HCl 
1 
97358 
OLEPTRO PO 
traZODone HCl 
1 
149210 
SPRAVATO (84 MG DOSE) NA 
Esketamine HCl 
1 
121369 
KHEDEZLA 100 MG PO TB24 
Desvenlafaxine Tab ER 24HR 100 MG 
1 
121368 
KHEDEZLA 50 MG PO TB24 
Desvenlafaxine Tab ER 24HR 50 MG 
1 
121839 
BRINTELLIX 5 MG PO TABS 
Vortioxetine HBr Tab 5 MG (Base Equiv) 
1 
101698 
SENTRAVIL PM-25 PO 
NULL 
1 
89054 
DESVENLAFAXINE SUCCINATE PO 
Desvenlafaxine Succinate 
1 
Notes: Trazodone less than 150mg, Amitriptyline, Nortriptyline, Imipramine, and Amoxapine may be excluded. NULL = Medication record is not linked to Generic 
Name. 
 

42 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
Appendix 3: ICD codes to identify patients with comorbidities  
Code Type 
Code or Code Range 
Condition 
ICD-9-CM DX 
3310 
Alzheimer’s 
ICD-10-CM DX 
G30.x 
Alzheimer’s 
ICD-9-CM DX 
14.x- 209.x 
Cancer 
ICD-10-CM DX 
C0.x-C96.x 
Cancer 
ICD-9-CM DX 
43.x-44.39; 7854, V434 
Cerebrovascular 
disease 
ICD-10-CM DX 
E08.x-E13.x; G45.x- 46.x; 
60.x-I79.x; I96; Z9582.x 
Cerebrovascular 
disease 
ICD-9-PROC 
3848 
Cerebrovascular 
disease 
ICD-10-PROC 
04R.x-04RY4KZ 
Cerebrovascular 
disease 
ICD-9-CM DX 
338.x 
Chronic pain 
ICD-10-CM DX 
G89.x 
Chronic pain 
ICD-9-CM DX 
428.x 
Congestive heart failure 
ICD-10-CM DX 
I09.x-I13.x; I50.x; R57.x 
Congestive heart failure 
ICD-9-CM DX 
49.x; 5064; 51.x; 7702 
COPD/asthma 
ICD-10-CM DX 
J4.x- J479 
COPD/asthma 
ICD-9-CM DX 
410.x-4149; 433.x 
Coronary artery/heart disease 
ICD-10-CM DX 
I20.x-I259; 63.x-I6529; Z955; Z9861 
Coronary artery/heart disease 
ICD-9-CM DX 
250.x 
Diabetes 
ICD-10-CM DX 
E10.x; E11.x; E13.x 
Diabetes 
ICD-9-CM DX 
345.x 
Epilepsy 
ICD-10-CM DX 
G40.x-G40B19 
Epilepsy 
ICD-9-CM DX 
00.x-129; 2515; 271.x-2892; 3064; 4474; 
45.x; 53.x-57.x; 61.x; 75.x; 78.x; 893.x; 
997.x 
GI disorders 
ICD-10-CM DX 
A0.x; A2.x; A4.x; A5.x; B0x; B3.x; B6.x; 
B7.x-B8.x; E164; E73.x-E74.x; I85.x-
1880; K2.x-K6.x; K9.x; N8.x; Q3.x-Q4.x; 
Q7.x; R10.x-R198 
GI disorders 
ICD-9-CM DX 
V08, 042, 07953 
HIV 
ICD-10-CM DX 
Z21, B20, B9735 
HIV 
ICD-9-CM DX 
401.x-404.93 
Hypertension 
ICD-10-CM DX 
I10.x-I132 
Hypertension 
ICD-9-CM DX 
346.x 
Migraine 
ICD-10-CM DX 
G430.x-G324B1 
Migraine 
ICD-9-CM DX 
278.0x 
Obesity 
ICD-10-CM DX 
E66.x 
Obesity 
ICD-9-CM DX 
715.x; 7330.x 
Osteoarthritis/osteoporosis 
ICD-10-CM DX 
M15.x-M19.x; M800.x; M81.x 
Osteoarthritis/osteoporosis 
ICD-9-CM DX 
331.82-33.2x 
Parkinson’s disease 
ICD-10-CM DX 
G20.x-G3183 
Parkinson’s disease 
ICD-9-CM DX 
240.x-2469 
Thyroid disease 
ICD-10-CM DX 
E00.x-E079 
Thyroid disease 
 
 
 

43 | P a g e  
Protocol Version 5.0 | 21 March 2022 
 
Appendix 4: OPTION-12 Questionnaire