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

This study has been terminated.
(recruitment difficulties)
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01178255
First received: August 9, 2010
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Major Depression
Drug: homeopathic q-potencies
Drug: Placebo
Other: homeopathic case history taking type I
Other: homeopathic case history type II
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Homeopathy for Depression: a Randomized, Partially Double-blind, Placebo Controlled, Four Armed Study DEP-HOM

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • primary endpoint is the mean total depression score post treatment [ Time Frame: six weeks ] [ Designated as safety issue: No ]
    total score on the 17-item Hamilton Depression Rating Scale - (HAM-D)


Secondary Outcome Measures:
  • mean total depression score during the treatment [ Time Frame: two and four weeks ] [ Designated as safety issue: No ]
    total score on Hamilton Depression Rating Scale (HAM-D)

  • response and remission rates [ Time Frame: two, four and six weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Beck Depression inventory (BDI) total score

  • quality of life assessment [ Time Frame: two, four and six weeks ] [ Designated as safety issue: No ]
    total mean score on the SF-12 Health Survey

  • Safety [ Time Frame: two, four and six weeks ] [ Designated as safety issue: Yes ]
    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


Enrollment: 44
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Drug: homeopathic q-potencies
individualised homeopathic medicines
Other Name: n.a.
Other: homeopathic case history taking type I
one special homeopathic technique for case history taking
Other Name: n.a.
Experimental: Group 2 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.
Experimental: Group 3 Drug: homeopathic q-potencies
individualised homeopathic medicines
Other Name: n.a.
Other: homeopathic case history type II
another type of homeopathic case history taking
Other Name: n.a.
Experimental: Group 4 Drug: Placebo
placebo
Other Name: n.a.
Other: homeopathic case history type II
another type of homeopathic case history taking
Other Name: n.a.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178255

Locations
Germany
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin, Germany
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Claudia M. Witt, MD Charite University, Berlin, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01178255     History of Changes
Other Study ID Numbers: DEP-HOM10, 2009-017458-11
Study First Received: August 9, 2010
Last Updated: July 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
depression
homoeopathy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014