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

Homeopathy for Depression: a Randomized, Partially Double-blind, Placebo Controlled, Four Armed Study DEP-HOM

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).

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.

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