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

NCT01178255 | Terminated Phase 3 DMC

• 2 other identifiers: DEP-HOM102009-017458-11
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depression

Keywords

depression; homoeopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• mean total depression score during the treatment

  two and four weeks

• response and remission rates

  two, four and six weeks

• Self-rated depression score

  two, four and six weeks

• quality of life assessment

  two, four and six weeks

• Safety

  two, four and six weeks

Study Arms (4)

Group 1

EXPERIMENTAL

Drug: homeopathic q-potencies; Other: homeopathic case history taking type I

Group 2

EXPERIMENTAL

Drug: Placebo; Other: homeopathic case history taking type I

Group 3

EXPERIMENTAL

Drug: homeopathic q-potencies; Other: homeopathic case history type II

Group 4

EXPERIMENTAL

Drug: Placebo; Other: homeopathic case history type II

Interventions

homeopathic q-potencies DRUG

individualised homeopathic medicines

Group 1; Group 3

Placebo DRUG

placebo

Group 2; Group 4

homeopathic case history taking type I OTHER

one special homeopathic technique for case history taking

Group 1; Group 2

homeopathic case history type II OTHER

another type of homeopathic case history taking

Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, State of Berlin, Germany

Location

Related Publications (2)

• 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.

  PMID: 21320338 BACKGROUND

• 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.

  PMID: 24086352 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Claudia M. Witt, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 10, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

DE (1)