NCT00169702已完成不适用
The Effect of a Weight Management Program to Prevent Weight Gain and Metabolic Abnormalities During Treatment With the Atypical Neuroleptic Olanzapine: A Randomised Study
Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- difference in mean weight gain
研究概览
简要总结
The study is a prospective, randomized, open-label study.
详细描述
The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
- •Ages between 18 and 65
- •Informed consent
- •Weight gain of at least 1.5 kg in the first 4 weeks
- •A sufficient understanding to participate adequately in the weight management program
- •Patients must agree to cooperate with all tests and examinations required by the protocol.
- •Each patient must understand the nature of the study and must sign an informed consent document.
排除标准
- •Serious, unstable somatic illnesses
- •Illnesses associated with weight gain including renal and endocrine diseases
- •Weight change greater than 3 kg in the preceding three months
- •Weight gain less than 1.5 kg in the first 4 weeks
结局指标
主要结局
difference in mean weight gain
时间窗: November 2007
次要结局
- changes in waist circumference, blood pressure, blood lipids, fasting glucose(November 2007)
研究者
研究点 (2)
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