OptimizeD Pilot Study

PHASE3CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

March 10, 2024

Study Completion Date

March 31, 2024

Conditions
DepressionDepressive Disorder
Interventions
BEHAVIORAL

Healthy Activity Program (HAP)

HAP, delivered over 6-8 sessions by non-specialist healthcare workers, has behavioural activation as the core psychological strategy along with other strategies such as problem-solving and activation of social networks.

DRUG

Antidepressant medication (ADM)

Patients assigned to antidepressant medication will start on fluoxetine 20 mg/day which can be raised to 40 mg/day (the maximum mandated by treatment guidelines for primary care in India) at week 3 or 6 for patients who have yet to remit. Patients who cannot tolerate fluoxetine will be switched to escitalopram.

Trial Locations (1)

462016

Sangath, Bhopal

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

Harvard School of Public Health (HSPH)

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

Centre for Addiction and Mental Health

OTHER

collaborator

Brigham and Women's Hospital

OTHER

collaborator

Vanderbilt University

OTHER

collaborator

All India Institute of Medical Sciences, Bhopal

OTHER

collaborator

Sangath

OTHER

lead

Harvard Medical School (HMS and HSDM)

OTHER