Improving Outcomes in Depression in Primary Care in a Low Resource Setting

The OptimizeD study aims to improve outcomes in depression in primary care in India. This study will randomize 1500 patients with moderate to severe depression to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine). The study has two primary objectives: 1. Use patient characteristics to generate a precision treatment rule based on baseline information for predicting in advance what works best for whom (and which patients are unlikely to respond to either treatment and should be referred to specialist care). 2. Conduct a cost-effectiveness analysis by comparing relative costs and effectiveness between those who were randomly allocated to their optimal treatment with those who were randomly allocated to a non-optimal treatment based on the precision treatment rule.

NCT Number	NCT05944926
Lead Sponsor	Harvard Medical School (HMS and HSDM) Collaborators: Sangath, All India Institute of Medical Sciences, Bhopal, Vanderbilt University, Brigham and Women's Hospital, Centre for Addiction and Mental Health, Massachusetts General Hospital, Harvard School of Public Health (HSPH), National Institute of Mental Health (NIMH)
Conditions	Depression, Depressive Disorder
Enrollment	1,500 participants
Start Date	2024-03-18
Primary Completion	2026-04-10 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-22