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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Major Depression

Intervention / Treatment
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* Drug: homeopathic q-potencies
* Drug: Placebo
* Other: homeopathic case history taking type I
* Other: homeopathic case history type II


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Drug: homeopathic q-potencies<br>* individualised homeopathic medicines<br>Other: homeopathic case history taking type I<br>* one special homeopathic technique for case history taking<br>|
| Experimental: Group 2<br> | Drug: Placebo<br>* placebo<br>Other: homeopathic case history taking type I<br>* one special homeopathic technique for case history taking<br>|
| Experimental: Group 3<br> | Drug: homeopathic q-potencies<br>* individualised homeopathic medicines<br>Other: homeopathic case history type II<br>* another type of homeopathic case history taking<br>|
| Experimental: Group 4<br> | Drug: Placebo<br>* placebo<br>Other: homeopathic case history type II<br>* another type of homeopathic case history taking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary endpoint is the mean total depression score post treatment | total score on the 17-item Hamilton Depression Rating Scale - (HAM-D) | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean total depression score during the treatment | total score on Hamilton Depression Rating Scale (HAM-D) | two and four weeks | 
| 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 | 
| Self-rated depression score | Beck Depression inventory (BDI) total score | two, four and six weeks | 
| quality of life assessment | total mean score on the SF-12 Health Survey | two, four and six weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, homoeopathy