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

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.

Conditions

• Depression
• Depressive 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 (fluoxetine)

Patients assigned to antidepressant medication will start on fluoxetine 20 mg/day and 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. Participants who do not tolerate fluoxetine can be switched to escitalopram at week 6 (10mg which can be titrated up to 20 mg).

Sponsors & Collaborators

• Sangath

  collaborator OTHER

• All India Institute of Medical Sciences, Bhopal

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Centre for Addiction and Mental Health

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Harvard Medical School (HMS and HSDM)

  lead OTHER

Principal Investigators

• Vikram Patel, MD · [email protected]

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-18

Primary Completion

2026-04-10

Completion

2026-12-31

Countries

• India

Study Locations