Clinical trial NCT01178255: Efficacy and Safety of Homeopathy for Moderate Depression (Acute Phase)
Official title: Homeopathy for Depression: a Randomized, Partially Double-blind, Placebo Controlled, Four Armed Study DEP-HOM
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depression
Keywords: depression
homoeopathy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: primary endpoint is the mean total depression score post treatment
timeFrame: six weeks
Secondary outcomes:
measure: mean total depression score during the treatment
timeFrame: two and four weeks
measure: response and remission rates
timeFrame: two, four and six weeks
measure: Self-rated depression score
timeFrame: two, four and six weeks
measure: quality of life assessment
timeFrame: two, four and six weeks
measure: Safety
timeFrame: two, four and six weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin, Germany
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia M. Witt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.