Efficacy and Safety of Homeopathy for Moderate Depression (Acute Phase) (DEP-HOM)
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About
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).
Full 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
44 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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