Homeopathy for Depression: a randomized, four-armed, partial double-blind study. - DEP-HOM

Phase 1

• Conditions: F32.1 Moderate Depressive Episode

• Registration Number: EUCTR2009-017458-11-DE
• Lead Sponsor: Institute for Social Medicine, Epidemiology, and Health Economics, Charité Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-24
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

Male and female patients between 18 and 65 years

Major Depression diagnose made by a psychiatrist

Willingness to comply with study procedures

Patients not using antidepressants or anxiolytic drugs (exception Lorazepam, maximal dose 1.5 mg/day as rescue medication)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

mild depressive Episode: Hamilton Depression Score (HAM-D) < 17)

severe depressive Episode (HAM-D > 24)

Schizophrenia or other psychotic disorders, bipolar affective disorder, schizoaffective disorders, alcohol or other substance abuse, eating disorders

clinically significant Axis II disorder

presence of a clinically significant acute or chronic disease that would hinder the regular participation in the study

a severe depression that has led to a suicide attempt in patients' history.

suicidal ideation of type 4 oder 5 on the C-SSRS in the last month (i.e. active suicidal ideation with some intent to act, without specific plan; or active suicidal ideation with specific plan and intent)

suicide thoughts according to an analysis made from a Psychiatrist

treatment with antipsychotics, antidepressants or sedatives/hypnotics or mood stabilizers 4 weeks prior to study entry

complementary or alternative treatment during the study (for example, acupuncture, phytotherapy, etc.)

Homeopathic treatment 8 weeks prior study entry

Psychotherapy

patients who are assumed to have a linguistic, intellectual or any other reason for not understanding the meaning of the clinical study and for not complying with the necessary study procedures

concomitant pregnancy or nursing

patients with pending pension application

persons who have been institutionalized by a court order

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the specific effect of an individualized homeopathic treatment with Q-potencies as compared to placebo for Major Depression (moderate depressive episode).<br><br>To assess the specific effect of a complete homeopathic patient history as compared to a rather conventional patient history.<br><br>;Secondary Objective: Effect of homeopathic medicines after 2 and 4 weeks compared to placebo, and effect of a complete homeopathic patient history compared to a rather conventional patient history. <br><br>Safety evaluation<br><br>Effect of homeopathic medicines and placebo using patient history/case analysis Type 1 (complete homeopathic patient history plus homeopathic questionnaire) compared to the effect of homeopathic medicines and placebo using patient history/case analysis Type 2 (rather conventional patient history plus homeopathic questionnaire) (interaction)<br>;Primary end point(s): mean HAM-D total score after 6 weeks