Efficacy and Safety of Homeopathy for Moderate Depression (Acute Phase)

Phase 3

Terminated

• Conditions: Major Depression
• Interventions: Drug: homeopathic q-potencies; Drug: Placebo; Other: homeopathic case history taking type I; Other: homeopathic case history type II

• Registration Number: NCT01178255
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	homeopathic q-potencies	-
Group 1	homeopathic case history taking type I	-
Group 2	Placebo	-
Group 3	homeopathic q-potencies	-
Group 2	homeopathic case history taking type I	-
Group 3	homeopathic case history type II	-
Group 4	Placebo	-
Group 4	homeopathic case history type II	-

Primary Outcome Measures

Name	Time	Method
primary endpoint is the mean total depression score post treatment	six weeks	total score on the 17-item Hamilton Depression Rating Scale - (HAM-D)

Secondary Outcome Measures

Name	Time	Method
mean total depression score during the treatment	two and four weeks	total score on Hamilton Depression Rating Scale (HAM-D)
response and remission rates	two, four and six weeks	response (decrease of 50% or more from baseline HAM-D score); remission (HAM-D scores ≤ 7)
Self-rated depression score	two, four and six weeks	Beck Depression inventory (BDI) total score
quality of life assessment	two, four and six weeks	total mean score on the SF-12 Health Survey
Safety	two, four and six weeks	Adverse events will be collected during the study and will form part of the secondary endpoint data in determining the safety of homeopathic medicines. Adverse events and serious adverse events will be registered in accordance with the ICH-Guidelines for Good Clinical Practice

Trial Locations

Locations (1)

Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin, Germany; 🇩🇪 Berlin, Germany