A Pilot Trial of Naltrexone-Bupropion Combination Versus Placebo Combined With Bupropion for Weight Loss in Comorbid Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- BMI
研究概览
简要总结
The purpose of this study is to determine the efficacy of combining open-label extended release bupropion (flexible dosing up to 450mg target) and naltrexone (37.5mg) versus Bupropion and placebo along with a daily 500 calorie reduction diet recommendation for weight and health risk reduction in 40 overweight/obese individuals with schizophrenia.
详细描述
The combination of naltrexone with noradrenaline/dopamine reuptake blocker bupropion has been developed and FDA-approved for the treatment of obesity in the general population. Naltrexone does not normally produce weight loss in humans and bupropion produces modest weight loss, however the combination produces clinically significant weight loss, which appears to be more than the sum of its components would otherwise produce separately. Of interest to us, the combination has been shown to be effective for clinically significant weight loss in obese subjects with type 2 diabetes as well. Registration studies by the manufacturer of the combination pill excluded antipsychotic medication users, thus we have no information on the potential effectiveness of the combination in this population. Both naltrexone and bupropion are commonly used in psychiatry, naltrexone for co-morbid alcohol addiction, and bupropion for co-morbid depression and/or cigarette addiction. This is a 16-week pilot trial of 37.5mg naltrexone/placebo added to extended release bupropion in flexible dosing (150mg to 450mg) and a daily 500 calorie reduction diet recommendation for subjects with schizophrenia and obesity. A dose of 37.5mg is similar to the FDA-approved combination dose for naltrexone. However, based on our experience with bupropion, we have chosen to use bupropion in an un-blinded manner and reach the target dose of 450mg based on tolerance of the individual subject over the initial 3-week period.
Changes to the study since registration:
The study was initially registered with 3 arms (Naltrexone vs Bupropion vs Placebo)- whereas the original intent was always supposed to be a 2 armed study (Naltrexone vs Placebo- each with Bupropion included)- this was corrected when the results of the terminated study were entered. In addition, there was an initial intent to include diabetics in the study, but this was later removed as well.
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)
盲法说明
Naltrexone versus Placebo assignment will remain double-blinded for the duration of the study; Bupropion dosing will be open-label and not masked to either participant or investigator.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Naltrexone with Bupropion
Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.
干预措施: Naltrexone (Drug)
Naltrexone with Bupropion
Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.
干预措施: Bupropion (Drug)
Placebo with Bupropion
Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.
干预措施: Bupropion (Drug)
Placebo with Bupropion
Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
BMI
时间窗: Baseline and Week 16
BMI will be calculated using weekly height and weight measurements (kg/m\^2) at each assessment.
次要结局
- Waist Circumference (Inches)(Baseline and Week 16)
- Weight (kg)(Baseline and Week 16)
- Health Risk Markers(Baseline to Week 16)