Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits
- Registration Number
- NCT00487942
- Lead Sponsor
- Cephalon
- Brief Summary
The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 (Any woman becoming pregnant during the study will be withdrawn from the study.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the placebo treatment arm for the double-blind treatment period of the study took four placebo tablets and no armodafinil tablets each morning. 50 mg/day armodafinil armodafinil Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 50 mg/day armodafinil treatment arm for the double-blind treatment period of the study took one 50 mg armodafinil tablet plus three placebo tablets each morning. 100 mg/day armodafinil armodafinil Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 100 mg/day armodafinil treatment arm for the double-blind treatment period of the study took two 50 mg armodafinil tablets plus two placebo tablets each morning. Subjects began taking 50 mg/day and then titrated to 100 mg/day on Day 2 of the first week of the double-blind treatment period. 200 mg/day armodafinil armodafinil Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 200 mg/day armodafinil treatment arm for the double-blind treatment period of the study took four 50 mg armodafinil tablet and no placebo tablets each morning. Subjects were titrated to this dose by starting treatment at 50 mg/day (1 tablet) and increasing by 50 mg increments on days 2, 4, and 6 until they were taking 200 mg/day.
- Primary Outcome Measures
Name Time Method 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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score Baseline and 4 weeks The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in composite T-score from baseline to 4 weeks.
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 Baseline 4 weeks (or last observation after baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Processing Speed Domain T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after baseline) The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Attention/Vigilance Domain T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Working Memory Domain T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Verbal Learning Domain T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Visual Learning Domain T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Reasoning and Problem Solving Domain T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Social Cognition Domain T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Trail Making Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Trail Making Test T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The BASC SC Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in BASC SC Test T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Fluency Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Fluency Test T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The WMS-III SS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in WMS-III SS T-score from baseline to last observation after baseline.
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 Baseline and 4 weeks (or last observation after Baseline) The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The LNS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in LNS T-score from baseline to last observation after baseline.
Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Number of Perseverative Errors 4 weeks (or last observation after baseline) WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only "right" or "wrong" to each placement. Examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. The change from baseline in number of perseveration errors was assessed.
Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Consecutive Responses on the Final Category Baseline and 4 weeks (or last observation after Baseline) WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only "right" or "wrong" to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of consecutive responses on the final category was assessed.
Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Categories Completed Baseline and 4 weeks (or last observation after Baseline) WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only "right" or "wrong" to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of sorting categories achieved was assessed.
Change From Baseline to Week 4 or Last Observation After Baseline in the Trails B Test Baseline and 4 weeks (or last observation after Baseline) Trail B is an instrument designed to assess set shifting. The patient was given a paper with numbers and letters on it and asked to connect them in an alternating manner (eg. 1-A-2-B-3C). The time required for the patient to complete the test was recorded. The change from Baseline to last observation following Baseline in the time necessary to complete the test is presented here.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Average Activity Baseline and Week 4 or last observation after baseline An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch).
Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity Baseline and Week 1 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch)to Week 1.
Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity Baseline and Week 2 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 2.
Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity Baseline and Week 3 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 3.
Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity Baseline and Week 4 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 4.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Maximum Activity Baseline and Week 4 or last observation after baseline An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in maximum activity to Endpoint.
Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity Baseline and Week 1 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in maximum activity.
Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity Baseline and Week 2 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in maximum activity.
Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity Baseline and Week 3 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in maximum activity.
Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity Baseline and Week 4 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in maximum activity.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Standard Deviation of Activity Baseline and Week 4 or last observation after baseline An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to endpoint in standard deviation of activity (counts/epoch).
Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity Baseline and Week 1 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in standard deviation of activity (counts/epoch).
Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity Baseline and Week 2 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in standard deviation of activity (counts/epoch).
Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity Baseline and Week 3 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in standard deviation of activity (counts/epoch).
Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity Baseline and Week 4 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in standard deviation of activity (counts/epoch).
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Total Activity Baseline and Week 4 or last observation after baseline An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.
Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity Baseline and Week 1 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.
Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity Baseline and Week 2 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.
Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity Baseline and Week 3 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.
Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity Baseline and Week 4 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Minimum Value for Actigraphy Data of Total Activity Baseline and Week 4 or last observation after baseline An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.
Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity Baseline and Week 1 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in total activity.
Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity Baseline and Week 2 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.
Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity Baseline and Week 3 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.
Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity Baseline and Week 4 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in total activity.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Maximum Value for Actigraphy Data of Total Activity Baseline and Week 4 or last observation after baseline An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.
Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity Baseline and Week 1 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.
Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity Baseline and Week 2 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.
Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity Baseline and Week 3 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.
Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity Baseline and Week 4 An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores Baseline and Week 4 or last observation after baseline The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.
Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores Baseline and 2 weeks following the start of study drug administration The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.
Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores Baseline and 4 weeks following the start of study drug administration The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.
Change From Baseline to Week 4 or Last Observation After Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating Baseline and 4 weeks (or last observation after Baseline) The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.
Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating Baseline and 2 weeks following the start of study drug administration n The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.
Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating Baseline and 4 weeks following the start of study drug administration The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline Baseline and 4 weeks (or last observation after Baseline) The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Endpoint which is Week 4 or the last observation following Baseline.
Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline Week 4 or last observation following Baseline The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 or at the last observation following Baseline is presented.
Change From Baseline to Week 4 or Last Observation After Baseline in Scale for the Assessment of Negative Symptoms (SANS) Total Scores Baseline and 4 weeks (or last observation after Baseline) SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Endpoint.
Change From Baseline to Week 1 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores Baseline and 1 week following the start of study drug administration SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 1.
Change From Baseline to Week 2 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores Baseline and 2 weeks following the start of study drug administration SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 2.
Change From Baseline to Week 4 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores Baseline and 4 weeks following the start of study drug administration SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 4.
Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score Baseline and 4 weeks (or last observation after Baseline) PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Endpoint.
Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score Baseline and 1 week following the start of study drug administration PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 1.
Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score Baseline and 2 weeks following the start of study drug administration PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 2.
Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score Baseline and 4 weeks following the start of study drug administration PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 4.
Change From Baseline to Week 4 or Last Observation Following Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score Baseline and 4 weeks (or last observation after Baseline) PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Endpoint.
Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score Baseline and 1 week following the start of study drug administration PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 1.
Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score Baseline and 2 weeks following the start of study drug administration PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 2.
Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score Baseline and 4 weeks following the start of study drug administration PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 4.
Change From Baseline to Week 4 or Last Observation Following Baseline in Epworth Sleepiness Scale (ESS) Total Scores Baseline and 4 weeks (or last observation after Baseline) ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Endpoint (Week 4 or last observation following baseline) in the ESS total score.
Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores Baseline and 1 week following the start of study drug administration ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 1 in the ESS total score.
Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores Baseline and 2 weeks following the start of study drug administration ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 2 in the ESS total score.
Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores Baseline and 4 weeks following the start of study drug administration ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 4 in the ESS total score.
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1 Baseline and 1 week The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 1.
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2 Baseline and 2 weeks The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 2.
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 Baseline and 4 weeks The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 4.
Patient Global Impression of Change (PGIC) at Week 1 Week 1 The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 1 is presented here.
Patient Global Impression of Change (PGIC) at Week 2 Week 2 The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 2 is presented here.
Patient Global Impression of Change (PGIC) at Week 4 Week 4 The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 is presented here.
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline Baseline The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Baseline.
Trial Locations
- Locations (12)
CNRI-Los Angeles, LLC
🇺🇸Pico Rivera, California, United States
Atlanta Center for Clinical Research
🇺🇸Atlanta, Georgia, United States
Collaborative NeuroScience Network
🇺🇸Garden Grove, California, United States
Synergy Clinical Research
🇺🇸National City, California, United States
University Hills Clinical Research
🇺🇸Irving, Texas, United States
California Clinical Trials
🇺🇸Paramount, California, United States
CNRI-San Diego
🇺🇸San Diego, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Duke Department of Psychiatry - DUMC
🇺🇸Durham, North Carolina, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States