NCT00624858已完成2 期
An Open-Label Study Assessing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) in Overweight or Obese Subjects With Major Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks
研究概览
简要总结
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of major depression in overweight or obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Female and male subjects must be 18 to 65 years of age;
- •Have body mass index (BMI) greater or equal to 27 and less than or to equal 43kg/m2;
- •Meet criteria for major depression
- •Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;
- •Able to comply with all required study procedures and schedule;
- •Able to speak and read English;
- •Willing and able to give written informed consent
排除标准
- •Obesity of known endocrine origin
- •Serious medical condition
- •History of drug or alcohol abuse or dependence
- •Use of excluded concomitant medications
- •History of surgical or device (e.g. gastric banding) intervention for obesity;
- •History or predisposition to seizures
- •Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
- •Planned surgical procedure that can impact the conduct of the study;
- •Use of investigational drug, device or procedure within 30 days prior to Screening;
- •Participation in any previous clinical trial conducted by Orexigen Therapeutics;
- •Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
研究组 & 干预措施
NB32
Experimental
Naltrexone SR 32 mg/Bupropion SR 360 mg/ day
干预措施: naltrexone SR 32 mg/ bupropion SR 360 mg daily (Drug)
结局指标
主要结局
To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks
时间窗: 12 Weeks
次要结局
- To assess the percentage change from baseline in total body weight at 12 and 24 weeks.(12 and 24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-DependentNicotine DependenceOverweightObesityNCT00563563Orexigen Therapeutics, Inc30
终止
2 期
Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in SchizophreniaObesitySchizophreniaDiabetes Mellitus, Type 2NCT03132571Yale University5
已完成
3 期
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR in Overweight and Obese SubjectsOverweightObesityNCT00567255Orexigen Therapeutics, Inc1,496
已完成
3 期
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification ProgramOverweightObesityNCT00456521Orexigen Therapeutics, Inc793
已完成
3 期
A Safety and Efficacy Study Comparing Naltrexone SR/Bupropion SR and Placebo in Obese Subjects With Type 2 DiabetesOverweightObesityDiabetes Mellitus, Type 2NCT00474630Orexigen Therapeutics, Inc505