Clinical trial NCT00487942: Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits
Official title: A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Cognitive Deficits Associated 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: 2007-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia


Eligibility criteria: Key Inclusion Criteria:

* The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria as determined by the SCID and has been clinically stable in a nonacute phase of their illness for at least 8 weeks prior to the baseline visit.
* 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 olanzapine, oral risperidone, or paliperidone for at least 4 weeks prior to the screening visit. The patient is prepared to remain at these stable dosages for the duration of the study.
* The patient is a man or woman 18 through 60 years of age.
* The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator on the basis of medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, and urinalysis.
* Women of childbearing potential 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.
* The patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.

Key Exclusion Criteria:

* The patient has any Axis I disorder, including schizoaffective disorder and sleep disorders, apart from schizophrenia, and nicotine dependence.
* The patient has tardive dyskinesia or any other clinically significant movement disorder.
* The patient has any clinically significant uncontrolled medical (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition.
* The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
* The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)

Primary outcomes:
measure: Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
Secondary outcomes:
measure: Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score
timeFrame: Baseline and 4 weeks
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline 4 weeks (or last observation after baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BASC SC) Test of the MATRICS Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Fluency Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Wechsler Memory Scale: Spatial Span (WMS-III SS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Letter-Number Span (LNS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Number of Perseverative Errors
timeFrame: 4 weeks (or last observation after baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Consecutive Responses on the Final Category
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Categories Completed
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Trails B Test
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Average Activity
timeFrame: Baseline and Week 4 or last observation after baseline
measure: Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity
timeFrame: Baseline and Week 1
measure: Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity
timeFrame: Baseline and Week 2
measure: Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity
timeFrame: Baseline and Week 3
measure: Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity
timeFrame: Baseline and Week 4
measure: Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Maximum Activity
timeFrame: Baseline and Week 4 or last observation after baseline
measure: Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity
timeFrame: Baseline and Week 1
measure: Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity
timeFrame: Baseline and Week 2
measure: Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity
timeFrame: Baseline and Week 3
measure: Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity
timeFrame: Baseline and Week 4
measure: Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Standard Deviation of Activity
timeFrame: Baseline and Week 4 or last observation after baseline
measure: Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity
timeFrame: Baseline and Week 1
measure: Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity
timeFrame: Baseline and Week 2
measure: Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity
timeFrame: Baseline and Week 3
measure: Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity
timeFrame: Baseline and Week 4
measure: Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 4 or last observation after baseline
measure: Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 1
measure: Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 2
measure: Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 3
measure: Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 4
measure: Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Minimum Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 4 or last observation after baseline
measure: Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 1
measure: Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 2
measure: Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 3
measure: Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 4
measure: Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Maximum Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 4 or last observation after baseline
measure: Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 1
measure: Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 2
measure: Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 3
measure: Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity
timeFrame: Baseline and Week 4
measure: Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores
timeFrame: Baseline and Week 4 or last observation after baseline
measure: Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline
timeFrame: Week 4 or last observation following Baseline
measure: Change From Baseline to Week 4 or Last Observation After Baseline in Scale for the Assessment of Negative Symptoms (SANS) Total Scores
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 1 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores
timeFrame: Baseline and 1 week following the start of study drug administration
measure: Change From Baseline to Week 2 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score
timeFrame: Baseline and 1 week following the start of study drug administration
measure: Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 or Last Observation Following Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score
timeFrame: Baseline and 1 week following the start of study drug administration
measure: Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 or Last Observation Following Baseline in Epworth Sleepiness Scale (ESS) Total Scores
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores
timeFrame: Baseline and 1 week following the start of study drug administration
measure: Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1
timeFrame: Baseline and 1 week
measure: Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2
timeFrame: Baseline and 2 weeks
measure: Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4
timeFrame: Baseline and 4 weeks
measure: Patient Global Impression of Change (PGIC) at Week 1
timeFrame: Week 1
measure: Patient Global Impression of Change (PGIC) at Week 2
timeFrame: Week 2
measure: Patient Global Impression of Change (PGIC) at Week 4
timeFrame: Week 4
measure: Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline
timeFrame: Baseline
Other outcomes:
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Modified Simpson-Angus Scale Total Score
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 1 in the Modified Simpson-Angus Scale Total Score
timeFrame: Baseline and 1 week following the start of study drug administration
measure: Change From Baseline to Week 2 in the Modified Simpson-Angus Scale Total Score
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 in the Modified Simpson-Angus Scale Total Score
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 or Last Observation Following Baseline in the Barnes Akathisia Scale (BARS) Total Score
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 1 in the Barnes Akathisia Scale (BARS) Total Score
timeFrame: Baseline and 1 week following the start of study drug administration
measure: Change From Baseline to Week 2 in the Barnes Akathisia Scale (BARS) Total Score
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 in the Barnes Akathisia Scale (BARS) Total Score
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 or Last Observation After Baseline on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 2 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score
timeFrame: Baseline and 4 weeks (or last observation after Baseline)
measure: Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score
timeFrame: Baseline and 1 week following the start of study drug administration
measure: Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score
timeFrame: Baseline and 4 weeks following the start of study drug administration
Locations:
city: Garden Grove
country: United States
facility: Collaborative NeuroScience Network
state: California
city: National City
country: United States
facility: Synergy Clinical Research
state: California
city: Paramount
country: United States
facility: California Clinical Trials
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
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Atlanta Center for Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Durham
country: United States
facility: Duke Department of Psychiatry - DUMC
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
Study officials:
References:
citation: Kane JM, D'Souza DC, Patkar AA, Youakim JM, Tiller JM, Yang R, Keefe RS. Armodafinil as adjunctive therapy in adults with cognitive deficits associated with schizophrenia: a 4-week, double-blind, placebo-controlled study. J Clin Psychiatry. 2010 Nov;71(11):1475-81. doi: 10.4088/JCP.09m05950gry. Epub 2010 Aug 24.