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

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany

Criteria

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