Clozapine Response and Biogenic Amines in Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Clinical measures: Brief Psychiatric Rating Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms, Simpson-Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale.
研究概览
简要总结
This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
详细描述
This is a longitudinal double-blind 12-week study of the clinical and biochemical response to clozapine or chlorpromazine in a group of treatment-refractory schizophrenic patients.
The study has 4 phases: (1) A recruitment period; (2) a period of discontinuation of psychotropic medication; (3) a drug-washout period; and (4) a 12-week double-blind trial of clozapine or chlorpromazine.
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
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-60 years of age
- •Diagnosis of schizophrenia
- •BPRS score > 50
- •Clinical Global Impressions rating > 4
- •One of the following: BPRS items rated greater than or equal to 4, conceptual disorganization, suspiciousness, hallucinations, unusual thought content.
- •At least 2 six-week trials of different neuroleptics given at a dosage equivalent to at least 600 mg per day of chlorpromazine OR at least 1 eight-week trial of a neuroleptic given at a dosage equivalent to at least 800 mg per day of chlorpromazine.
- •The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent.
排除标准
- •History of substance dependence within the past 2 months
- •Major medical problems precluding the use of clozapine
- •Pregnancy or lactation
- •A serious suicide/homicide risk
结局指标
主要结局
Clinical measures: Brief Psychiatric Rating Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms, Simpson-Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale.
次要结局
- Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.
研究者
AlanGreen
Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth
Harvard Medical School (HMS and HSDM)