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

NCT ID: NCT01178255

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-07-31

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.

Conditions

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Major Depression

Keywords

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depression homoeopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Group Type EXPERIMENTAL

homeopathic q-potencies

Intervention Type DRUG

individualised homeopathic medicines

homeopathic case history taking type I

Intervention Type OTHER

one special homeopathic technique for case history taking

Group 2

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

placebo

homeopathic case history taking type I

Intervention Type OTHER

one special homeopathic technique for case history taking

Group 3

Group Type EXPERIMENTAL

homeopathic q-potencies

Intervention Type DRUG

individualised homeopathic medicines

homeopathic case history type II

Intervention Type OTHER

another type of homeopathic case history taking

Group 4

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

placebo

homeopathic case history type II

Intervention Type OTHER

another type of homeopathic case history taking

Interventions

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homeopathic q-potencies

individualised homeopathic medicines

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

homeopathic case history taking type I

one special homeopathic technique for case history taking

Intervention Type OTHER

homeopathic case history type II

another type of homeopathic case history taking

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia M. Witt

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia M. Witt, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin, Germany

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 21320338 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24086352 (View on PubMed)

Other Identifiers

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2009-017458-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DEP-HOM10

Identifier Type: -

Identifier Source: org_study_id