Homeopathy for Depression: a Randomized, Partially Double-blind, Placebo Controlled, Four Armed Study DEP-HOM
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- primary endpoint is the mean total depression score post treatment
研究概览
简要总结
To assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history taking(defined in this study as case history taking type I and II).
详细描述
Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the taking of the case history and the prescription of an individually selected homeopathic remedy. Homeopathic medicines are produced through sequential, agitated dilutions. A Q-Potency is prepared by grinding the raw material, followed by a process of consecutive 1:50.000 agitated dilutions.
Previous data suggest that individualized homeopathic Q-potencies were non inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe major depression. The question remains whether individualized homeopathic Q-potencies have a specific therapeutical effect in acute depression as this has not yet been investigated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of major depression by a psychiatrist,
- •patients must not be currently taking antidepressants or anxiolytic drugs (with the exception of Lorazepam as rescue medication, maximal dose 1.5 mg/day)
- •Capability and willingness to give informed consent and to comply with the study procedures will also be required
排除标准
- •current mild episode of depression (HAM-D < 17)
- •current severe episode of depression (HAM-D > 24)
- •schizophrenia or other psychotic disorders
- •bipolar affective disorder
- •schizoaffective disorders
- •alcohol or other substance abuse
- •eating disorders
- •a clinically significant (Diagnostic and Statistical Manual of Mental Disorders)-Axis II disorder
- •severe depression, which previously motivated a suicide attempt
- •a score of 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS)up to three months before screening;
- •a clinically significant acute or chronic disease that would hinder regular participation in the study
- •treatment with antipsychotics, antidepressants, sedatives/hypnotics or mood stabilizers four weeks prior to the screening
- •complementary or alternative treatment simultaneously to the study (for example, acupuncture, phytotherapy, etc.)
- •homeopathic treatment eight weeks prior to study entry
- •psychotherapy
- •simultaneous participation in another clinical trial (the last participation in a previous clinical trial must be completed at least three months prior to screening)
- •concomitant pregnancy or breastfeeding
- •patients who are assumed to have a linguistic, intellectual or any other reason for not understanding the meaning of the clinical trial and for not complying with the necessary study procedures
- •persons who have been institutionalized by a court order
- •patients with an application for a pension
研究组 & 干预措施
Group 1
干预措施: homeopathic q-potencies (Drug)
Group 1
干预措施: homeopathic case history taking type I (Other)
Group 2
干预措施: Placebo (Drug)
Group 2
干预措施: homeopathic case history taking type I (Other)
Group 3
干预措施: homeopathic q-potencies (Drug)
Group 3
干预措施: homeopathic case history type II (Other)
Group 4
干预措施: Placebo (Drug)
Group 4
干预措施: homeopathic case history type II (Other)
结局指标
主要结局
primary endpoint is the mean total depression score post treatment
时间窗: six weeks
total score on the 17-item Hamilton Depression Rating Scale - (HAM-D)
次要结局
- mean total depression score during the treatment(two and four weeks)
- response and remission rates(two, four and six weeks)
- Self-rated depression score(two, four and six weeks)
- quality of life assessment(two, four and six weeks)
- Safety(two, four and six weeks)
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany