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

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

Plain Language Summary

Simplified for easier understanding

This trial is studying better ways to identify and treat moderate-to-severe depression in primary care settings in low-resource communities. **You may be eligible if...** - You are 18 or older - You are attending a primary health care clinic and have been identified with moderate-to-severe depression (PHQ-9 score of 10 or above) - You speak English or Hindi **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a history of psychosis, schizophrenia, or bipolar disorder - You plan to move out of the study area before follow-up is complete - You have cognitive impairment - You are currently being treated for depression, or completed treatment within the last month - You are at immediate risk of suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).


Locations(1)

Sangath

Bhopal, Madhya Pradesh, India

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NCT05944926


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