NCT00845988已完成4 期
Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders Having Drug-induced Weight Gain
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
- 28
- 试验地点
- 1
- 主要终点
- Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K
研究概览
简要总结
The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.
详细描述
- reduced treatment adherence due to metabolic side effects
- suggested advantages of aripiprazole in metabolic profile over other antipsychotics or mood stabilizers
- randomized trial of switch from previous drugs to aripiprazole
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria
- •age between 18 and 65
- •Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3
- •patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain)
排除标准
- •diagnosis of eating disorder, substance abuse, and psychotic disorder
- •history of neurological and medical illness
- •pregnant or breast feeding women
研究组 & 干预措施
treatment as usual
Active Comparator
patients showing weight gain while receiving treatment with risperidone, olanzapine, quetiapine, or clozapine
干预措施: aripiprazole (Drug)
switch to aripiprazole
Experimental
aripiprazole
干预措施: aripiprazole (Drug)
结局指标
主要结局
Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K
时间窗: 0, 4, 8, 12, 18, 26 week
次要结局
- ECG prolactin SAS BAS UKU-SERS-Pat-Korean version(0, 4, 8, 12, 18, 26 week)
研究者
Kyooseob Ha
Professor
Seoul National University Bundang Hospital
研究点 (1)
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