Clozapine vs. Olanzapine: An Effectiveness Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Changes in quality of life.
研究概览
简要总结
This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment.
详细描述
This is a two-year open-label, randomized trial of the comparative effectiveness of clozapine versus olanzapine in patients with treatment refractory schizophrenia. The objective is to determine whether in a naturalistic setting olanzapine is a logical treatment choice (before using the more toxic clozapine) for some treatment refractory patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-60 years;
- •Diagnosis of treatment refractory schizophrenia or schizoaffective disorder;
- •BPRS score > 21 (0-6) scale;
- •Either two 6-8 week trials of typical neuroleptics given at a dosage of 600 mg/day of CPZ or its equivalent or one 6-8 week trial of an atypical antipsychotic at a reasonable dose (i.e. risperidone 4-6 mg/day);
- •The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
- •Clinically appropriate for clozapine or olanzapine
排除标准
- •Current substance abuse;
- •Suicide or homicide risk;
- •Pregnancy or lactation;
- •History of seizures or blood dyscrasias
研究组 & 干预措施
Clozapine
Clozapine or olanzapine in treatment resistant schizophrenia
干预措施: Clozapine (Drug)
olanzapine
clozapine or olanzapine in treatment resistant schizophrenia
干预措施: Olanzapine (Drug)
结局指标
主要结局
Changes in quality of life.
次要结局
- Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.
研究者
AlanGreen
Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth
National Institute of Mental Health (NIMH)