Background: Common mental disorders are associated with substantial morbidity and disability in developing countries, but there are no data for efficacy of treatment. We aimed to assess the efficacy and cost-effectiveness of antidepressant and psychological treatment for common mental disorders in general health-care settings.
Method: We did a randomised, placebo-controlled trial (double-blind for the antidepressant group) in general outpatient clinics in two district hospitals in Goa, India. Consecutive eligible adults who scored more than 15 on the Revised Clinical Interview Schedule (n=450) were randomly assigned to antidepressant (fluoxetine), placebo, or psychological treatment. Antidepressant or placebo was provided for up to 6 months. Up to six sessions of psychological treatment were provided by trained therapists. The primary outcome was psychiatric morbidity; secondary outcomes were disability and costs. Outcome measurements were done at 2, 6, and 12 months. Intention-to-treat analyses were done with linear regression.
Findings: 80% of patients were reviewed; the number of drop-outs was similar in all three groups. Psychiatric outcome was significantly better with antidepressant than with placebo at 2 months (p=0.02; standardised effect size 0.3), but not over the 2-12 month period (p=0.10); antidepressants were significantly more cost effective than placebo in the short term and long term (p<0.05). Psychological treatment was not more effective than placebo for any outcome during either period.
Interpretation: Affordable antidepressants such as fluoxetine should be the treatment of choice for common mental disorders in general health-care settings in India, since they are associated with improved clinical and economic outcomes, especially in the short term.