Improving Outcomes in Depression in Primary Care in a Low Resource Setting
Status:
RECRUITING
Trial end date:
2027-03-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
PHASE3
Details
Lead Sponsor:
Harvard Medical School (HMS and HSDM)
Collaborators:
All India Institute of Medical Sciences, Bhopal Brigham and Women's Hospital Centre for Addiction and Mental Health Harvard School of Public Health (HSPH) Massachusetts General Hospital National Institute of Mental Health (NIMH) Sangath Vanderbilt University