Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment
研究概览
简要总结
The objective of the study was to study the effects of donepezil on cognition in patients with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.
详细描述
The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.The trial will be complete in 2012.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of schizophrenia as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders-Clinician Version;
- •Between 18 and 40 years of age;
- •Duration of the illness must be longer than 2 year;
- •Patient's current antipsychotic medication regimen must be stable;
- •Must be in a stable living arrangement;
排除标准
- •Patient has mental retardation or severe organic brain syndromes;
- •Treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening;
- •Has suicidal attempts or ideation or violent behavior within the last 12 months;
- •Patient has a history of alcohol/drug dependence;
研究组 & 干预措施
placebo
Subjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally.
干预措施: placebo (Drug)
donepezil
Subjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally.
干预措施: Donepezil (Drug)
结局指标
主要结局
Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment
时间窗: 12 weeks
次要结局
- Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment(12 weeks)
研究者
xiaofeng Guo
Principal Investigator
Central South University