RecruitingPhase 3NCT05944926

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

Sponsor

Harvard Medical School (HMS and HSDM)

Enrollment

1,500 participants

Start Date

Mar 18, 2024

Study Type

INTERVENTIONAL

Conditions

Depression Depressive Disorder

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

Participants will be adults aged 18 or over of any gender attending one of the selected Primary Health Care Centers with a "diagnosis" of moderate to severe depression based on scores of 10 or above on the Patient Health Questionnaire-9 (PHQ-9).

Exclusion Criteria8

Women who are pregnant or are breastfeeding or lactating
Patients with a history of psychosis, including schizophrenia spectrum disorders or bipolar disorder.
Participants planning to permanently move out of the study area during the follow-up period.
Patients with evidence of cognitive impairment.
Patients who do not speak either English or Hindi.
Patients who are undergoing treatment for depression at the time of recruitment or who completed treatment within one month prior to recruitment
Patients at imminent risk for suicide
Patients from households in which another member has been recruited into the study

Interventions

BEHAVIORALHealthy 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.

DRUGAntidepressant 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).