NCT02953639已完成2 期
A Phase IIb, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Basmisanil (RO5186582) as Adjunctive Treatment in Patients With Cognitive Impairment Associated With Schizophrenia Treated With Antipsychotics
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 37
- 主要终点
- Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score
研究概览
简要总结
This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia of any type utilizing the Mini International Neuropsychiatric Interview and diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) direct clinical assessments, family informants and past medical records
- •Evidence of stability of symptoms for 3 months at screening, that is, without hospitalizations for schizophrenia or increase in level of psychiatric care due to worsening of symptoms of schizophrenia
- •Participants with schizophrenia clinical symptom severity defined by the following: hallucinatory behavior item score less than or equal to (</=) 5 and a delusion item score </= 5 of the PANSS
- •Participants on a stable regimen of antipsychotic therapy for at least 3 months at screening and receiving no more than two antipsychotics
排除标准
- •Participants with current DSM-5 diagnosis other than schizophrenia including bipolar disorder, schizoaffective disorder and major depressive disorder
- •Clinically significant neurological illness or significant head trauma that affects cognitive function, in the judgment of the principal investigator
- •Full scale intelligence quotient </=65 on the Wechsler Abbreviated Scale of Intelligence at screening
- •Positive result at screening for hepatitis B, hepatitis C, or human immunodeficiency virus-1 and 2
- •Moderate to severe substance use disorder (other than nicotine or caffeine), as defined by the DSM-5, within the last 12 months
- •Suicide attempt within 1 year or currently at risk of suicide in the opinion of the Investigator
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.
干预措施: Placebo (Drug)
Basmisanil 80mg BID
Experimental
Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.
干预措施: Basmisanil (Drug)
Basmisanil 240mg BID
Experimental
Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.
干预措施: Basmisanil (Drug)
结局指标
主要结局
Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score
时间窗: Baseline up to Week 24
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite T-score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher composite T-score represents lower impairment.
次要结局
- Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score(Baseline up to Week 24)
- Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores(Baseline up to Week 24)
- Apparent Clearance of Basmisanil at Steady State (CL/F,ss)(Pre-dose (hour 0) in Days 7, 14, 42, 84, 168)
- Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss)(Pre-dose (hour 0) in Days 7, 14, 42, 84, 168)
- Change From Baseline to Week 24 in MCCB Cognitive Domain Scores(Baseline up to Week 24)
- Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score(Baseline up to Week 24)
- Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score(Baseline up to Week 24)
- Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score(Baseline up to Week 24)
- Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating(Baseline up to Week 24)
- Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating(Baseline up to Week 24)
- Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS)(Baseline up to Week 24)
- Percentage of Participants With Adverse Events (AEs)(Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks))
- Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss)(Pre-dose (hour 0) in Days 7, 14, 42, 84, 168)
- Area Under the Curve of Basmisanil at Steady State (AUC,ss)(Pre-dose (hour 0) in Days 7, 14, 42, 84, 168)
研究者
研究点 (37)
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