NCT00604760Unknown2 期
A Phase 2a, Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MEM 3454 as Adjunctive Treatment in Combination With a Preexisting Antipsychotic in Patients With Cognitive Impairment Associated With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 160
- 试验地点
- 43
- 主要终点
- Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.
研究概览
简要总结
To establish the proof of concept that MEM 3454, used as add-on pharmacotherapy, is a safe and effective treatment in patients with cognitive impairment associated with schizophrenia (CIAS).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia (any subtype), assessed using a structured interview.
- •At least one month on the same dose of antipsychotic medication.
- •Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks.
- •Able to provide informed consent.
- •Fluent in English.
- •Smokers and non-smokers.
排除标准
- •First 3 years of schizophrenia diagnosis.
- •Current risk of suicide, or history of suicidal behavior within the last 6 months.
- •Hospitalized for psychiatric symptoms in the past 3 months.
- •Other psychiatric diagnoses.
- •Substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according.
- •Nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix).
研究组 & 干预措施
A
Experimental
干预措施: MEM 3454 (Drug)
B
Experimental
干预措施: MEM 3454 (Drug)
C
Experimental
干预措施: MEM 3454 (Drug)
D
Placebo Comparator
干预措施: Placebo for MEM 3454 (Drug)
结局指标
主要结局
Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.
时间窗: Change from baseline at wk 8.
次要结局
- Change from baseline in the total composite score of the MATRICS cognitive battery at Weeks 4 and 10(Change from baseline - weeks 4 and 10)
- Change from baseline on the various cognition tests at Weeks 4, 8 and 10(Change from baseline at Weeks 4, 8 and 10)
- Functional Assessments Change from baseline on the following tests at Week 8 and 10: UPSA-2 and PSP(Change from baseline at weeks 8 and 10)
- Adverse events(weeks 2, 4, 6, 8, 10)
研究者
研究点 (43)
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