NCT00487942已完成2 期
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
Cephalon12 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- 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
研究概览
简要总结
The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.)
研究组 & 干预措施
50 mg/day armodafinil
Active Comparator
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.
干预措施: armodafinil (Drug)
100 mg/day armodafinil
Active Comparator
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.
干预措施: armodafinil (Drug)
200 mg/day armodafinil
Active Comparator
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.
干预措施: armodafinil (Drug)
Placebo
Placebo Comparator
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.
干预措施: placebo (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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)
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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)
- Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity(Baseline and Week 1)
- Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity(Baseline and Week 2)
- Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity(Baseline and Week 3)
- Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity(Baseline and 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)
- Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity(Baseline and Week 1)
- Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity(Baseline and Week 2)
- Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity(Baseline and Week 3)
- Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity(Baseline and Week 4)
- 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)
- Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity(Baseline and Week 1)
- Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity(Baseline and Week 2)
- Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity(Baseline and Week 3)
- Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity(Baseline and Week 4)
- 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)
- Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity(Baseline and Week 1)
- Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity(Baseline and Week 2)
- Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity(Baseline and Week 3)
- Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity(Baseline and Week 4)
- 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)
- Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity(Baseline and Week 1)
- Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity(Baseline and Week 2)
- Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity(Baseline and Week 3)
- Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity(Baseline and Week 4)
- 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)
- Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity(Baseline and Week 1)
- Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity(Baseline and Week 2)
- Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity(Baseline and Week 3)
- Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity(Baseline and Week 4)
- 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)
- 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)
- 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)
- 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))
- 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)
- 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)
- 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))
- Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline(Week 4 or last observation following Baseline)
- 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))
- 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)
- 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)
- 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)
- 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))
- 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)
- 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)
- 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)
- 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))
- 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)
- 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)
- 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)
- 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))
- Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores(Baseline and 1 week following the start of study drug administration)
- Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores(Baseline and 2 weeks following the start of study drug administration)
- Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores(Baseline and 4 weeks following the start of study drug administration)
- Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1(Baseline and 1 week)
- Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2(Baseline and 2 weeks)
- Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4(Baseline and 4 weeks)
- Patient Global Impression of Change (PGIC) at Week 1(Week 1)
- Patient Global Impression of Change (PGIC) at Week 2(Week 2)
- Patient Global Impression of Change (PGIC) at Week 4(Week 4)
- Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline(Baseline)
研究者
研究点 (12)
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