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Clinical Trials/CTRI/2024/01/061932
CTRI/2024/01/061932RecruitingPhase 3

Improving outcomes in Depression in Primary Care in a Low resource setting

Harvard University1 site in 1 country1,500 target enrollmentStarted: March 15, 2024Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
1,500
Locations
1
Primary Endpoint
Depressive symptoms: measured by the Patient Health Questionnaire-9 (PHQ-9)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The OptimizeD study aims to improve outcomes in depression in primary care in India. As part of this study, we 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 objective of OptimizeD is to generate a precision treatment rule (PTR) for predicting which patient will respond better to either of the two monotherapies in routine primary care.

Study Design

Study Type
Interventional
Allocation
Stratified block randomization
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Participants will be adults aged 18 or over of any gender attending one of eight 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 Criteria

  • •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 move out of the study area during the follow-up period.
  • •Patients over 65 years of age with evidence of cognitive impairment.
  • •Patients who do not speak the study or local language (English or Hindi).
  • •Patients who are undergoing treatment for depression at the time of recruitment.

Outcomes

Primary Outcomes

Depressive symptoms: measured by the Patient Health Questionnaire-9 (PHQ-9)

Time Frame: Baseline (week 0), during acute treatment (week 1, 2, 3, 6), primary endpoint (week 12), & follow-up assessments (6-, 9-, 12-month)

Secondary Outcomes

  • Generalized Anxiety Disorder Assessment (GAD-7)
  • World Health Organization Well-Being Index (WHO-5)
  • WHO Disability Assessment Schedule II (WHODAS-II)(Baseline, 3 months, 6 months, 9 months, 12 months)
  • Minimal Clinically Important Difference (MCID)(3 months)
  • Client Sociodemographic & Service Receipt Inventory (CSSRI)(Baseline, 3 months, 6 months, 9 months, 12 months)

Investigators

Sponsor Class
Research institution

Study Sites (1)

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