Efficacy outcomes in the MDD-1 India study: First episode major depressive disorder outcomes in antidepressant-treated real-world patients in India.

OBJECTIVES

Little is known about the outcome of major depressive disorder in India, especially in primary care contexts not usually associated with research. This large, prospective, naturalistic observational study examined the feasibility of studying first-episode major depressive disorder outcomes in such contexts, and examined outcomes after antidepressant drug treatment.

METHODS

A convenience sample of 205 psychiatrists across India each recruited five adults with first-episode major depressive disorder. No patient had clinically significant suicidal ideation, psychotic symptoms, or significant medical or psychiatric comorbidity. Patients were naturalistically treated with antidepressant medication and rated using the Montgomery-Asberg Depression Rating Scale and other instruments, including patient-reported outcome measures. Assessments were obtained at baseline and at a 6-week follow-up.

RESULTS

Of 900 patients recruited, 92 did not meet selection criteria, and there were 10 dropouts, leaving 798 evaluable patients. The most common antidepressants received were desvenlafaxine, vilazodone, and escitalopram. The primary outcome, response (50% attenuation of Montgomery-Asberg Depression Rating Scale score), was identified in 66.1% of the sample. The patient-reported outcome measures-defined response rate was 53.1%. Remission (endpoint Montgomery-Asberg Depression Rating Scale score of 10 or less) was observed in 36.7% of the sample. Response (but not remission) was very slightly but significantly better in women than in men on some but not all measures.

CONCLUSIONS

It is feasible to conduct simple but meaningful observational studies in primary care contexts that are not usually associated with research. About two-thirds of real-world adults in primary care in India diagnosed with uncomplicated first-episode major depressive disorder respond to 6 weeks of antidepressant medications; about one-third of the adults remit.