Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00487942
First received: June 15, 2007
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: armodafinil
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline 4 weeks (or last observation after baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks (or last observation after baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 or last observation after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 or last observation after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 or last observation after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 or last observation after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 or last observation after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 or last observation after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 or last observation after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 2 weeks following the start of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks following the start of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 2 weeks following the start of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks following the start of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 4 or last observation following Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1 week following the start of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 2 weeks following the start of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks following the start of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 1 week following the start of study drug administration ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 2 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 4 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 1 week following the start of study drug administration ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 2 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 4 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1 week following the start of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 2 weeks following the start of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks following the start of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Change From Baseline to Week 4 or Last Observation After Baseline in the Modified Simpson-Angus Scale Total Score [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: Yes ]
    The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline.

  • Change From Baseline to Week 1 in the Modified Simpson-Angus Scale Total Score [ Time Frame: Baseline and 1 week following the start of study drug administration ] [ Designated as safety issue: Yes ]
    The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 1.

  • Change From Baseline to Week 2 in the Modified Simpson-Angus Scale Total Score [ Time Frame: Baseline and 2 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 2.

  • Change From Baseline to Week 4 in the Modified Simpson-Angus Scale Total Score [ Time Frame: Baseline and 4 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4.

  • Change From Baseline to Week 4 or Last Observation Following Baseline in the Barnes Akathisia Scale (BARS) Total Score [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: Yes ]
    The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

  • Change From Baseline to Week 1 in the Barnes Akathisia Scale (BARS) Total Score [ Time Frame: Baseline and 1 week following the start of study drug administration ] [ Designated as safety issue: Yes ]
    The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

  • Change From Baseline to Week 2 in the Barnes Akathisia Scale (BARS) Total Score [ Time Frame: Baseline and 2 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

  • Change From Baseline to Week 4 in the Barnes Akathisia Scale (BARS) Total Score [ Time Frame: Baseline and 4 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

  • Change From Baseline to Week 4 or Last Observation After Baseline on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: Yes ]
    The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline in the total score.

  • Change From Baseline to Week 2 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score [ Time Frame: Baseline and 2 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 2 in the total score.

  • Change From Baseline to Week 4 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score [ Time Frame: Baseline and 4 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 in the total score.

  • Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score [ Time Frame: Baseline and 4 weeks (or last observation after Baseline) ] [ Designated as safety issue: Yes ]
    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 Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Endpoint.

  • Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score [ Time Frame: Baseline and 1 week following the start of study drug administration ] [ Designated as safety issue: Yes ]
    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 Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 1.

  • Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score [ Time Frame: Baseline and 2 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    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 Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 2.

  • Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score [ Time Frame: Baseline and 4 weeks following the start of study drug administration ] [ Designated as safety issue: Yes ]
    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 Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 4.


Enrollment: 60
Study Start Date: July 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 50 mg/day 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.
Drug: armodafinil
50 mg/day armodafinil
Active Comparator: 100 mg/day 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.
Drug: armodafinil
100 mg/day armodafinil
Active Comparator: 200 mg/day 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.
Drug: armodafinil
200 mg/day armodafinil
Placebo Comparator: 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.
Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487942

Locations
United States, California
Collaborative NeuroScience Network
Garden Grove, California, United States, 92845
Synergy Clinical Research
National City, California, United States, 91950
California Clinical Trials
Paramount, California, United States, 90723
CNRI-Los Angeles, LLC
Pico Rivera, California, United States, 90660
CNRI-San Diego
San Diego, California, United States, 92126
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Georgia
Atlanta Center for Clinical Research
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
United States, North Carolina
Duke Department of Psychiatry - DUMC
Durham, North Carolina, United States, 27705
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
United States, Texas
University Hills Clinical Research
Irving, Texas, United States, 75062
Sponsors and Collaborators
Cephalon
  More Information

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sponsor's Medical Expert, Cephalon
ClinicalTrials.gov Identifier: NCT00487942     History of Changes
Other Study ID Numbers: C10953/2033/SZ/US
Study First Received: June 15, 2007
Results First Received: April 30, 2010
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014