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

Primary Purpose

Major Depression

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
homeopathic q-potencies
Placebo
homeopathic case history taking type I
homeopathic case history type II
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring depression, homoeopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Outcomes

Primary Outcome Measures

primary endpoint is the mean total depression score post treatment
total score on the 17-item Hamilton Depression Rating Scale - (HAM-D)

Secondary Outcome Measures

mean total depression score during the treatment
total score on Hamilton Depression Rating Scale (HAM-D)
response and remission rates
response (decrease of 50% or more from baseline HAM-D score); remission (HAM-D scores ≤ 7)
Self-rated depression score
Beck Depression inventory (BDI) total score
quality of life assessment
total mean score on the SF-12 Health Survey
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

Full Information

First Posted
August 9, 2010
Last Updated
July 9, 2012
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01178255
Brief Title
Efficacy and Safety of Homeopathy for Moderate Depression (Acute Phase)
Acronym
DEP-HOM
Official Title
Homeopathy for Depression: a Randomized, Partially Double-blind, Placebo Controlled, Four Armed Study DEP-HOM
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
depression, homoeopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Experimental
Arm Title
Group 3
Arm Type
Experimental
Arm Title
Group 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
homeopathic q-potencies
Intervention Description
individualised homeopathic medicines
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Intervention Type
Other
Intervention Name(s)
homeopathic case history taking type I
Intervention Description
one special homeopathic technique for case history taking
Intervention Type
Other
Intervention Name(s)
homeopathic case history type II
Intervention Description
another type of homeopathic case history taking
Primary Outcome Measure Information:
Title
primary endpoint is the mean total depression score post treatment
Description
total score on the 17-item Hamilton Depression Rating Scale - (HAM-D)
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
mean total depression score during the treatment
Description
total score on Hamilton Depression Rating Scale (HAM-D)
Time Frame
two and four weeks
Title
response and remission rates
Description
response (decrease of 50% or more from baseline HAM-D score); remission (HAM-D scores ≤ 7)
Time Frame
two, four and six weeks
Title
Self-rated depression score
Description
Beck Depression inventory (BDI) total score
Time Frame
two, four and six weeks
Title
quality of life assessment
Description
total mean score on the SF-12 Health Survey
Time Frame
two, four and six weeks
Title
Safety
Description
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
Time Frame
two, four and six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia M. Witt, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin, Germany
City
Berlin
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21320338
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.
Results Reference
background
PubMed Identifier
24086352
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.
Results Reference
derived

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

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