Major Depressive Disorder
Conditions
Interventions
Homeopathy: Individualized homeopathic medication following the method of the sixth edition of the Organon Placebo: Indistinguishable solution containing 20 ml of 30% alcohol, administered in the sam
Sponsors
Federal University of Ceara. Hospital Universitario Walter Cantidio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women and men at age over 18 years, with a diagnosis of a Major Depressive Episode given by a psychiatrist, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), presenting a therapeutic response (reduction greater than or equal to 50 percent of the baseline depression score, kept for at least four weeks) during a prior open homeopathic treatment, with or without concomitant use of psychotropic drugs. The capacity to understand and agree and a written consent form with the terms and procedures of the study will be necessary for inclusion.
Exclusion criteria
Exclusion criteria: Suicidal behavior (defined as attempted suicide within 24 months) and psychotic symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of the Beck-II Depression Inventory (BDI-II), self-evaluated by the participant in weeks 0-2-4-8-12-16-20-24-28 and analyzed throughout the study in homeopathy and placebo partitions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluated in weeks 0-2-4-8-12-16-20-24-28: score of the Clinical Global Impression Scale; mental and physical health scores assessed by the 12-Item Short-Form Health Survey (SF-12); participant's blinded preference for verum or placebo treatment at each block; clinically substantial worsening (characterized by an augmentation in BDI inclusion score greater than or equal to 30%), and Adverse Events. | — |
Countries
South America
Contacts
Public ContactLia Sanders
Federal University of Ceara Department of Medicine
Outcome results
None listed