NCT00455442已完成2 期
A Two-Week, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain in Healthy Male Volunteers
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.
研究概览
简要总结
This is a two-week study testing the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight and BMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers between 18 and 40 years of age
- •BMI between ≥ 18 and ≤ 25
- •Able to provide written informed consent
- •Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits
排除标准
- •History of Cushing's syndrome or Addison's disease
- •Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
- •Positive urine drug screen for any non-prescribed drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines)
- •Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
- •Have a history of an allergic reaction to either mifepristone or olanzapine
- •Any clinically significant abnormality on screening laboratory tests
- •QTc Bazzett's ≥ 450 msec
- •Any major medical condition, which in the opinion of the Investigator would place the patient at undue risk.
- •Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight
- •History of recent (within 6 months of screening) significant weight fluctuation
结局指标
主要结局
To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.
次要结局
- To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers.
研究者
研究点 (1)
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