NCT00707382已完成不适用
A Three-armed Randomised Controled Trial on the Effect of Genotyping for CYP450 Polymorphisms and Intense Clinical Monitoring on Antipsychotic Drug Treatment.
Gesche Jurgens2 个研究点 分布在 1 个国家目标入组 311 人开始时间: 2008年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 311
- 试验地点
- 2
- 主要终点
- Time to discontinuation of initial antipsychotic treatment
研究概览
简要总结
The purpose of this study is to determine whether genotyping for CYP2D6 and 2C19 polymorphisms or intense clinical monitoring of treatment and adverse effects improves the antipsychotic treatment in patients with schizophrenia. This study is designed as a three-armed prospective randomized controlled clinical trial and includes 300 patients with schizophrenia. Patients are followed for a period of one year.
During the study period the following effect measures are registered:
- Time to discontinuation of all antipsychotic medications
- Number of changes in medication dose
- Number of changes in medication
- Compliance (patients´ adherence to medical treatment)
- Clinical symptoms
- Adverse effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with schizophrenia
- •Able to give written informed consent
排除标准
- •Genotyped prior to inclusion
结局指标
主要结局
Time to discontinuation of initial antipsychotic treatment
时间窗: one year
次要结局
- Compliance(one year)
研究者
Gesche Jurgens
MD, PhD
Bispebjerg Hospital
研究点 (2)
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