NCT01103271已完成2 期
Harnessing the Placebo Effect in Major Depressive Disorder
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
Placebo pills (pills with no active ingredients) have been shown in research studies to somehow produce self-healing processes. The purpose of this study is to determine whether people will be willing to enter an open-label non-deceptive placebo treatment for Major Depressive Disorder (MDD) and whether open-label placebo can be effective for treating MDD in the context of a supportive physician-patient relationship.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18-60 years old.
- •Current Major Depressive Disorder (MDD)
排除标准
- •Pregnant women or women of child bearing potential not using a medically accepted means of contraception.
- •Patients who are a serious suicide or homicide risk.
- •Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
- •The following Diagnostic and Statistical Manual of Mental Disorders-IV diagnoses: 1) organic mental disorders; 2) substance use disorders, including alcohol, active within the last year; 3) schizophrenia; 4) delusional disorder; 5) psychotic disorders not elsewhere classified; 6) bipolar disorder; 7) acute bereavement; 9) severe borderline or antisocial personality disorder; 10) current primary diagnoses of panic disorder, social phobia, generalized anxiety disorder (GAD), or obsessive compulsive disorder (OCD) (disorders that present as chief complaint and/or have their onset preceding the onset of major depressive disorder).
- •Uncontrolled seizure disorder.
- •Patients with mood congruent or mood incongruent psychotic features.
- •Current use of other psychotropic drugs. Exception: Patients who have been on a stable dose for 30 days of classes of medications such as non-benzodiazepine sedatives, anxiolytic benzodiazepines, non-narcotic analgesics may be included. Flexibility will be allowed based on physician discretion.
- •Clinical or laboratory evidence of hypothyroidism.
- •Patients who have taken an investigational psychotropic drug within the last year.
- •Patients who have not responded to two or more antidepressant trials of adequate doses (e.g., fluoxetine 40 mg/day or higher) and duration (e.g.,for six weeks or more) over the past five years.
- •Any concomitant form of psychotherapy (depression focused)
结局指标
主要结局
Feasibility
时间窗: One year
The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.
次要结局
- Pre-Post Efficacy(Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment))
研究者
Maurizio Fava, MD
Director, Depression Clinical and Research Program
Massachusetts General Hospital
研究点 (2)
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