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

Major Depression Clinical Trial

— DEP-HOM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01178255
• Other study ID #: DEP-HOM10
• Secondary ID: 2009-017458-11
• Status: Terminated
• Phase: Phase 3
• First received: August 9, 2010
• Last updated: July 9, 2012
• Start date: August 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• homeopathic q-potencies
individualised homeopathic medicines
• Placebo
placebo

Other:
• homeopathic case history taking type I
one special homeopathic technique for case history taking
• homeopathic case history type II
another type of homeopathic case history taking

Locations

Country	Name	City	State
Germany	Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin, Germany	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Adler UC, Krüger S, Teut M, Lüdtke R, Bartsch I, Schützler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary endpoint is the mean total depression score post treatment	total score on the 17-item Hamilton Depression Rating Scale - (HAM-D)	six weeks	No
Secondary	mean total depression score during the treatment	total score on Hamilton Depression Rating Scale (HAM-D)	two and four weeks	No
Secondary	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	No
Secondary	Self-rated depression score	Beck Depression inventory (BDI) total score	two, four and six weeks	No
Secondary	quality of life assessment	total mean score on the SF-12 Health Survey	two, four and six weeks	No
Secondary	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	Yes