NCT00169026终止4 期
Alcoholism and Schizophrenia: Effects of Clozapine
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Self report using the weekly Time Line Follow Back; Alcohol Use Scale and Drug Use Scale obtained by clinician and key informant; breathalyzer and urine drug screen. Monthly consensus in substance use rating; monthly CDT and clozapine blood levels.
研究概览
简要总结
The purpose of this study is to examine the short - term effects of clozapine on alcohol use in persons with schizophrenia and an alcohol use disorder. The hypothesis is that clozapine will have greater efficacy in reducing alcohol use than other antipsychotic medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder
- •Current diagnosis of an alcohol use disorder with active use in the last 30 days.
- •The participant (or the participant's authorized legal representative) understands the nature of the study and has he/she signed an informed consent.
- •Taking olanzapine, risperidone, quetiapine or a typical antipsychotic agent for at least 8 weeks prior to study randomization
- •If taking depot medication, at least 3 injection cycles since the last injection prior to study randomization.
排除标准
- •Contraindication to clozapine
- •Women who are currently pregnant or who desire to become pregnant during the course of the study.
- •Current and past treatment with clozapine
- •Current treatment with agents proposed to curtail substance use (e.g., disulfiram, naltrexone, acamprosate, buspirone) and agents contraindicated for use with clozapine (e.g., inderal, tegretol, lithium).
- •Meets DSM-IV criteria for current dependence of substances other than alcohol.
结局指标
主要结局
Self report using the weekly Time Line Follow Back; Alcohol Use Scale and Drug Use Scale obtained by clinician and key informant; breathalyzer and urine drug screen. Monthly consensus in substance use rating; monthly CDT and clozapine blood levels.
次要结局
- Clinical Measures: Brief Psychiatric Rating Scale; Scale for the Assessment of Negative Symptoms; and Clinical Global Impression; neurological side affects, cognitive assessment and quality of life measure.
研究者
Alan Green
Principal Investigator
Dartmouth-Hitchcock Medical Center
研究点 (2)
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