Clinical trial NCT00772005: Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia
Official title: A 24-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (150, 200, and 250 mg/ Day) as Adjunctive Therapy in Adults With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia

Detailed description: This study was designed and was powered to evaluate the efficacy and safety of armodafinil treatment at dosages of 150, 200, and 250 mg/day compared with placebo over 24 weeks as an adjunctive therapy to antipsychotic medication (olanzapine, oral risperidone, or paliperidone) in adults with schizophrenia who were clinically stable at study entry. Specifically, the effects of armodafinil treatment on the negative symptoms of schizophrenia were the primary assessment in this study.

Eligibility criteria: Key Inclusion Criteria:

* The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria and the patient has been clinically stable in a nonacute phase of their illness.
* Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit.
* The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator.
* Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence.
* The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits.

Key Exclusion Criteria:

* The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale.
* The patient has any Axis I disorder according to DSM-IV-TR criteria, including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study.
* The patient has moderate to severe depressive symptoms, as indicated by the CDSS.
* The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
* The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder.
* The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies.
* The patient is a pregnant or lactating woman.
* The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.

Primary outcomes:
measure: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint
timeFrame: Baseline and Endpoint (Week 24 or last observation after baseline)
Secondary outcomes:
measure: Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint
timeFrame: Baseline and Endpoint (Week 24 or last observation after baseline)
measure: Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1
timeFrame: Baseline and Week 1
measure: Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2
timeFrame: Baseline and Week 2
measure: Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4
timeFrame: Baseline and Week 4
measure: Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8
timeFrame: Baseline and Week 8
measure: Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16
timeFrame: Baseline and Week 16
measure: Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20
timeFrame: Baseline and Week 20
measure: Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1
timeFrame: Baseline and Week 1
measure: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2
timeFrame: Baseline and Week 2
measure: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4
timeFrame: Baseline and Week 4
measure: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8
timeFrame: Baseline and Week 8
measure: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16
timeFrame: Baseline and Week 16
measure: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20
timeFrame: Baseline and Week 20
measure: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score
timeFrame: Baseline and Week 1
measure: Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
timeFrame: Baseline and Week 4
measure: Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
timeFrame: Baseline and Week 8
measure: Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
timeFrame: Baseline and Week 20
measure: Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
timeFrame: Baseline and Endpoint (Week 24 or last observation after baseline)
measure: Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
timeFrame: Baseline and Week 1
measure: Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
timeFrame: Baseline and Week 4
measure: Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
timeFrame: Baseline and Week 8
measure: Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
timeFrame: Baseline and Week 20
measure: Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 1
measure: Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 4
measure: Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 8
measure: Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 20
measure: Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 1
measure: Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 4
measure: Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 8
measure: Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 20
measure: Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 1
measure: Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 4
measure: Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 8
measure: Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 20
measure: Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 1
measure: Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 4
measure: Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 8
measure: Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 20
measure: Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 1
measure: Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 4
measure: Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 8
measure: Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 20
measure: Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and Week 24
measure: Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 1
measure: Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 2
measure: Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 6
measure: Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 10
measure: Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 14
measure: Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 18
measure: Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 22
measure: Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores
timeFrame: Baseline and Week 4
measure: Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]
timeFrame: Baseline and Week 24
measure: Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
timeFrame: Baseline and Week 1
measure: Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
timeFrame: Baseline and Week 2
measure: Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
timeFrame: Baseline and Week 4
measure: Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
timeFrame: Baseline and Week 8
measure: Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
timeFrame: Baseline and Week 12
measure: Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
timeFrame: Baseline and Week 16
measure: Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
timeFrame: Baseline and Week 20
measure: Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores
timeFrame: Baseline and Week 24
measure: Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
timeFrame: Baseline and Week 1
measure: Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
timeFrame: Baseline and Week 2
measure: Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
timeFrame: Baseline and Week 4
measure: Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
timeFrame: Baseline and Week 8
measure: Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
timeFrame: Baseline and Week 12
measure: Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
timeFrame: Baseline and Week 16
measure: Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
timeFrame: Baseline and Week 20
measure: Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score
timeFrame: Baseline and Week 1
measure: Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score
timeFrame: Baseline and Week 2
measure: Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
timeFrame: Baseline and Week 1
measure: Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
timeFrame: Baseline and Week 2
measure: Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score
timeFrame: Baseline and Week 24
measure: Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint
timeFrame: Endpoint (Week 24 or last observation)
measure: Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8
timeFrame: Week 8
measure: Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16
timeFrame: Week 16
measure: Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24
timeFrame: Week 24
measure: Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint
timeFrame: Endpoint (Week 24 or last observation)
measure: Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8
timeFrame: Week 8
measure: Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16
timeFrame: Week 16
measure: Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24
timeFrame: Week 24
measure: Change From Baseline to Endpoint in Sleep Latency
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Change From Baseline to Week 12 in Sleep Latency
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 24 in Sleep Latency
timeFrame: Baseline and Week 24
measure: Change From Baseline to Endpoint in Number of Nighttime Awakenings
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Change From Baseline to Week 12 in Number of Nighttime Awakenings
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 24 in Number of Nighttime Awakenings
timeFrame: Baseline and Week 24
measure: Change From Baseline to Endpoint in Time Spent Awake at Night
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Change From Baseline to Week 12 in Time Spent Awake at Night
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 24 in Time Spent Awake at Night
timeFrame: Baseline and Week 24
measure: Change From Baseline to Endpoint in Time Spent Asleep at Night
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Change From Baseline to Week 12 in Time Spent Asleep at Night
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 24 in Time Spent Asleep at Night
timeFrame: Baseline and Week 24
measure: Change From Baseline to Endpoint in Sleep Quality Rating
timeFrame: Baseline and Endpoint (Week 24 or last observation)
measure: Change From Baseline to Week 12 in Sleep Quality Rating
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 24 in Sleep Quality Rating
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K and S Professional Research Services, LLC
state: Arkansas
city: Anaheim
country: United States
facility: Omega Clinical Trials
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research Center
state: California
city: Garden Grove
country: United States
facility: Collaborative NeuroScience
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Pico Rivera
country: United States
facility: CNRI Los Angeles LLC
state: California
city: San Diego
country: United States
facility: CNRI-San Diego LLC
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Torrance
country: United States
facility: Collaborative NeuroScience Network
state: California
city: New Britain
country: United States
facility: The Hospital of Central Connecticut
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Aventura
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Boca Raton
country: United States
facility: Mental Health Advocates. Inc
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Comprehensive Neuroscience Inc
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute. LLC
state: Illinois
city: Wichita
country: United States
facility: Via Christi Research
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Glen Burnie
country: United States
facility: Clinical Insights
state: Maryland
city: Towson
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: St Louis
country: United States
facility: St Louis Clinical Trials LC
state: Missouri
city: Clementon
country: United States
facility: CRI Worldwide LLC
state: New Jersey
city: Brooklyn
country: United States
facility: Behavioral Medical Research of Brooklyn
state: New York
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research of Staten Island
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Norristown
country: United States
facility: Keystone Clinical Studies LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Belmont Center for Comprehensive Treatment
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials. Inc
state: South Carolina
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References:
citation: Kane JM, Yang R, Youakim JM. Adjunctive armodafinil for negative symptoms in adults with schizophrenia: a double-blind, placebo-controlled study. Schizophr Res. 2012 Mar;135(1-3):116-22. doi: 10.1016/j.schres.2011.11.006. Epub 2011 Dec 16.