The Safety and Efficacy of Naltrexone and Scopolamine Utilized in Combination in the Treatment of Major Depression: A Double Blinded, Randomized, Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period
研究概览
简要总结
The purpose of this clinical trial is to determine the safety and efficacy of scopolamine utilized in conjunction with naltrexone for the treatment of major depression.
详细描述
The study will be a double blinded, randomized controlled trial. The medications will be administered orally. The sample size will be 40 participants, 20 in the treatment group and 20 in the control group. The study period will be 4 weeks. Eligible participants will have major depression by history for at least 8 weeks, between 18-65 years old, and in generally good health other than depression. The MADRS questionaire will be utilized to determine the response to the medications.
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
- Double (Participant, Care Provider)
盲法说明
The participants and physician are both blinded to medication vs. control medication
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
- 是
入选标准
- •male or female, aged 18-65
- •in good health other than major depression for 8 weeks or more
- •negative pregnancy test
- •able to comply with instructions
- •able to provide informed consent
排除标准
- •pregnant or lactating
- •danger to self or others
- •severe kidney or liver disease
- •schizophrenia
- •allergy to scopolamine or naltrexone
- •Monoamine oxidase (MAO) inhibitor use
研究组 & 干预措施
control
Participants will receive placebo medication
干预措施: placebo arm (Drug)
Active
participants will receive active medications scopolamine and naltrexone
干预措施: Scopolamine and naltrexone (Drug)
结局指标
主要结局
Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period
时间窗: Baseline and 4 weeks
The Montgomery-Asberg (MADRS) depression scale will be utilized throughout the study. The scale is scored 0-60, 0 signifying no depression symptoms and 60 signifying very severe depression. A diagnosis of depression will be given to a participant in this study for a MADRS score of 20 or greater. A clinical response to medication will be noted when a participant has a 25% or greater decrease in MADRS score during the trial.
次要结局
未报告次要终点
研究者
Neal Taub MD
Principle Investigator
The Taub Group