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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01178255
Recruitment Status : Terminated (recruitment difficulties)
First Posted : August 10, 2010
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):
Claudia M. Witt, 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).

Condition or disease Intervention/treatment Phase
Major Depression Drug: homeopathic q-potencies Drug: Placebo Other: homeopathic case history taking type I Other: homeopathic case history type II Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Homeopathy for Depression: a Randomized, Partially Double-blind, Placebo Controlled, Four Armed Study DEP-HOM
Study Start Date : August 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 2 Drug: Placebo

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

Other: homeopathic case history type II
another type of homeopathic case history taking

Primary Outcome Measures :
  1. primary endpoint is the mean total depression score post treatment [ Time Frame: six weeks ]
    total score on the 17-item Hamilton Depression Rating Scale - (HAM-D)

Secondary Outcome Measures :
  1. mean total depression score during the treatment [ Time Frame: two and four weeks ]
    total score on Hamilton Depression Rating Scale (HAM-D)

  2. response and remission rates [ Time Frame: two, four and six weeks ]
    response (decrease of 50% or more from baseline HAM-D score); remission (HAM-D scores ≤ 7)

  3. Self-rated depression score [ Time Frame: two, four and six weeks ]
    Beck Depression inventory (BDI) total score

  4. quality of life assessment [ Time Frame: two, four and six weeks ]
    total mean score on the SF-12 Health Survey

  5. Safety [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01178255

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Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin, Germany
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Claudia M. Witt, MD Charite University, Berlin, Germany
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany Identifier: NCT01178255    
Other Study ID Numbers: DEP-HOM10
2009-017458-11 ( EudraCT Number )
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012
Keywords provided by Claudia M. Witt, Charite University, Berlin, Germany:
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders