Depressive episode
Conditions
Interventions
Experimental group: 110 patients with a depressive episode diagnosis will receive an individualized homeopathic medicine in fifty-millesimal potencies (LM or Q potencies)
Control group: 110 patients
Drug
Sponsors
Unidade de Saúde Escola da Universidade Federal de São Carlos
Unidade de Saúde Escola da Universidade Federal de São Carlos
Eligibility
Age
No minimum to 70 Years
Inclusion criteria
Inclusion criteria: Subjects should meet the criteria for a depressive episode (single or recurrent) following a Structured Clinical Interview,SCID; capacity and willingness to give informed consent and to comply with study procedures will also be required.
Exclusion criteria
Exclusion criteria: Dysthymia; psychotic, chronic or double depression; intolerance to sertraline or a negative previous experience with the drug; bipolar disorder; schizophrenia or other psychotic disorders; substance dependence (except tobacco); bulimia or anorexia, clinical significant chronic disease that could hinder study visits or depression evaluation; suicide attempt up to 12 months before screening; treatment with antidepressants or mood stabilizers 4 weeks prior to the screening; homeopathic treatment 8 weeks prior to study entry; psychotherapy, meditation or acupuncture during the study; participation in a previous clinical trial 3 months prior to screening; concomitant pregnancy or breastfeeding; epilepsy; concomitant use of anticoagulants; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean score on the Montgomery & Åsberg – (MADRS) after twelve weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| MADRS mean score (with the exception of the primary endpoint); response and remission rates, quality of life (SF-12), at weeks 2, 4, 8, 16, 20, and 24; adverse events and dropouts during the whole trial. | — |
Countries
Brazil
Contacts
Public ContactUbiratan;Ubiratan Adler;Adler
Unidade de Saúde Escola da Universidade Federal de São Carlos;Unidade de Saúde Escola da Universidade Federal de São Carlos
Outcome results
None listed