Surveillance Study of Weight Response and Body Composition in Subjects Taking a Stable Dose of Risperdal, Seroquel, and/or Zyprexa for Greater Than 3 Months 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 been taking a stable dose of certain anti-psychotic medications for longer than three months.
详细描述
A total of 80 subjects will be enrolled in this study: 20 subjects will be randomized to receive placebo, and 60 will be randomized to receive the investigational product (20 who are on a stable dose of Seroquel, 20 who are on a stable dose of Risperdal, and 20 who are on a stable dose of Zyprexa). The investigational product or placebo will be taken 15 minutes prior to the three main meals of the day. Subjects will continue to take their prescribed anti-psychotic medications. Participation in this study involves four 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
- •Currently on a stable dose of Risperdal (Risperidone), Seroquel (Quetiapine) and/or Zyprexa (Olanzapine) for at least three 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)