Surveillance Study of Weight Response and Body Composition in Subjects Who Are First-Time Users (Less Than 3 Months) of the Following Medications: Risperdal, Seroquel, and/or Zyprexa, in Combination With 500 mg IHBG-10 TID
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight change and changes in body composition in subjects who have just started taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel, and/or Zyprexa).
详细描述
A total of 30 subjects will be enrolled in this study. They will be randomized in to one of two groups. One group (of 20 subjects) will take 500 mg of the investigational product (IHBG-10) 15 minutes prior to the three main meals of the day; subjects will continue to take their prescribed anti-psychotic medications. The other group (of 10 subjects) will take a placebo 15 minutes prior to the three main meals of the day; subjects will continue to take their prescribed anti-psychotic medications. Subjects will take the investigational product or placebo for 12 weeks. Participation in this study involves 4 study visits.
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
- 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
- •Men and women, age 18 and older
- •Agree to keep diet, exercise and all current health habits stable during participation in the study
- •Have been taking Risperdal (Risperidone), Seroquel (Quetiapine), or Zyprexa (Olanzapine) for less than 3 months
排除标准
- •Current active acute psychotic episode
- •Women who are pregnant, breastfeeding or planning to become pregnant
- •Prior bariatric surgery
- •Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
- •Obesity as a result of a clinically-diagnosed endocrine problem
结局指标
主要结局
Weight
时间窗: 12 weeks
次要结局
- Body composition(12 weeks)