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

Homeopathy for Depression: a Randomized, Partially Double-blind, Placebo Controlled, Four Armed Study DEP-HOM

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).

Study Overview

• Status: Terminated
• Conditions: Major Depression
• Intervention / Treatment: Drug: Placebo; Drug: homeopathic q-potencies; Other: homeopathic case history taking type I; Other: homeopathic case history type 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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2	Drug: Placebo; placebo; Other: homeopathic case history taking type I; one special homeopathic technique for case history taking
Experimental: Group 1	Drug: homeopathic q-potencies; individualised homeopathic medicines; Other: homeopathic case history taking type I; one special homeopathic technique for case history taking
Experimental: Group 3	Drug: homeopathic q-potencies; individualised homeopathic medicines; Other: homeopathic case history type II; another type of homeopathic case history taking
Experimental: Group 4	Drug: Placebo; placebo; Other: homeopathic case history type II; another type of homeopathic case history taking

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean total depression score during the treatment	total score on Hamilton Depression Rating Scale (HAM-D)	two and four weeks
response and remission rates	response (decrease of 50% or more from baseline HAM-D score); remission (HAM-D scores ≤ 7)	two, four and six weeks
Self-rated depression score	Beck Depression inventory (BDI) total score	two, four and six weeks
quality of life assessment	total mean score on the SF-12 Health Survey	two, four and six weeks
Safety	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	two, four and six weeks

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Claudia M. Witt, MD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Adler UC, Kruger S, Teut M, Ludtke R, Bartsch I, Schutzler L, Melcher F, Willich SN, Linde K, Witt CM. Homeopathy for depression--DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study. Trials. 2011 Feb 14;12:43. doi: 10.1186/1745-6215-12-43.
• Adler UC, Kruger S, Teut M, Ludtke R, Schutzler L, Martins F, Willich SN, Linde K, Witt CM. Homeopathy for depression: a randomized, partially double-blind, placebo-controlled, four-armed study (DEP-HOM). PLoS One. 2013 Sep 23;8(9):e74537. doi: 10.1371/journal.pone.0074537. eCollection 2013.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: August 9, 2010
• First Submitted That Met QC Criteria: August 9, 2010
• First Posted (Estimate): August 10, 2010

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 9, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: depression; homoeopathy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: DEP-HOM10; 2009-017458-11 (EudraCT Number)