NCT00148564已完成4 期
Energy Homeostasis and Metabolism in Patients With Schizophrenic Disorders Under Treatment With Atypical Antipsychotics
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment
研究概览
简要总结
The purpose of this study is to evaluate the effects of different atypical antipsychotics on weight changes, energy homeostasis, metabolism, energy intake as well as activity.
Patients with schizophrenia or schizoaffective disorders will be randomly assigned to be treated with ziprasidone or olanzapine for 24 weeks.
Primary outcome parameter are the weight changes after 24 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or related disorders(DSM-IV)
- •Indication for long-term treatment with antipsychotics
- •BMI between 20 to 30
- •Weight changes less than 3kg in the last 3 months before inclusion
- •Informed consent
排除标准
- •Psychiatric comorbidity
- •Depot antipsychotic in the last 2 months
- •Antipsychotics in the last 2 weeks
- •Treatment with olanzapine, clozapine or ziprasidone in teh last 3 months
- •Treatment with drugs, that may lead to weight changes
- •Significant endocrine, neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests
- •Female subjects during pregnancy and breastfeeding
- •Female subjects within childbearing years who were not using adequate birth control
- •Patients who are judged by the investigator to be at serious suicide risk
研究组 & 干预措施
Olanzapine
Active Comparator
干预措施: olanzapine (Drug)
Zpirasidone
Active Comparator
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment
时间窗: during treatment
次要结局
- Changes in energy homeostasis, food intake, metabolism(during and after treatment)
研究者
研究点 (1)
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