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

This study has been terminated.
(recruitment difficulties)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178255
First Posted: August 10, 2010
Last Update Posted: July 10, 2012
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.
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
August 9, 2010
August 10, 2010
July 10, 2012
August 2010
July 2011   (Final data collection date for primary outcome measure)
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)
primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale - (HAM-D) [ Time Frame: six weeks ]
Complete list of historical versions of study NCT01178255 on ClinicalTrials.gov Archive Site
  • mean total depression score during the treatment [ Time Frame: two and four weeks ]
    total score on Hamilton Depression Rating Scale (HAM-D)
  • 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)
  • Self-rated depression score [ Time Frame: two, four and six weeks ]
    Beck Depression inventory (BDI) total score
  • quality of life assessment [ Time Frame: two, four and six weeks ]
    total mean score on the SF-12 Health Survey
  • 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
  • Hamilton Depression Rating Scale (HAM-D) total score [ Time Frame: two and four weeks ]
  • response and remission rates [ Time Frame: two, four and six weeks ]
  • Beck Depression inventory (BDI) total score [ Time Frame: two, four and six weeks ]
  • quality of life (SF-12) [ Time Frame: two, four and six weeks ]
Not Provided
Not Provided
 
Efficacy and Safety of Homeopathy for Moderate Depression (Acute Phase)
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).

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depression
  • Drug: homeopathic q-potencies
    individualised homeopathic medicines
    Other Name: n.a.
  • Drug: Placebo
    placebo
    Other Name: n.a.
  • Other: homeopathic case history taking type I
    one special homeopathic technique for case history taking
    Other Name: n.a.
  • Other: homeopathic case history type II
    another type of homeopathic case history taking
    Other Name: n.a.
  • Experimental: Group 1
    Interventions:
    • Drug: homeopathic q-potencies
    • Other: homeopathic case history taking type I
  • Experimental: Group 2
    Interventions:
    • Drug: Placebo
    • Other: homeopathic case history taking type I
  • Experimental: Group 3
    Interventions:
    • Drug: homeopathic q-potencies
    • Other: homeopathic case history type II
  • Experimental: Group 4
    Interventions:
    • Drug: Placebo
    • Other: homeopathic case history type II

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
44
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01178255
DEP-HOM10
2009-017458-11 ( EudraCT Number )
Yes
Not Provided
Not Provided
Claudia M. Witt, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Claudia M. Witt, MD Charite University, Berlin, Germany
Charite University, Berlin, Germany
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP