F32.1 Moderate Depressive Episode
Conditions
Interventions
Trade Name: V (individualized homeopathic Q-Potencies registered under ATC-Code V60A )
Pharmaceutical Form: Oral drops, solution
Pharmaceutical form of the placebo: Oral drops, solution
Route of admin
Sponsors
Institute for Social Medicine, Epidemiology, and Health Economics, Charité Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: mild depressive Episode: Hamilton Depression Score (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). To assess the specific effect of a complete homeopathic patient history as compared to a rather conventional patient history. ;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. Safety evaluation 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) ;Primary end point(s): mean HAM-D total score after 6 weeks | — |
Countries
Germany
Outcome results
None listed