Improving depression outcomes in primary care in India
Improving Outcomes in Depression in Primary Care in a Low Resource Setting
This study is testing whether a new therapy program or an antidepressant can help people with moderate to severe depression in India feel better and which treatment works best for different individuals.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Harvard Medical School (HMS and HSDM) Academic / other |
| Locations | 1 site (Bhopal, Madhya Pradesh) |
| Trial ID | NCT05944926 on ClinicalTrials.gov |
What this trial studies
The OptimizeD study aims to enhance treatment outcomes for patients with moderate to severe depression in primary care settings in India. It will randomly assign 1500 participants to receive either a behavioral activation psychotherapy program called the Healthy Activity Program (HAP) or the antidepressant fluoxetine. The study's primary objectives include developing a precision treatment rule to identify which patients are likely to benefit from each treatment and conducting a cost-effectiveness analysis comparing the outcomes of optimal versus non-optimal treatment allocations. This research addresses a critical gap in understanding how to tailor depression treatments to individual patient needs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a diagnosis of moderate to severe depression attending selected primary health care centers.
Not a fit: Patients with a history of psychosis, cognitive impairment, or those at imminent risk for suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with depression, improving overall mental health outcomes.
How similar studies have performed: Other studies have shown promise in using precision treatment approaches for depression, but this specific methodology in a low-resource setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: 1. Women who are pregnant or are breastfeeding or lactating 2. Patients with a history of psychosis, including schizophrenia spectrum disorders or bipolar disorder. 3. Participants planning to permanently move out of the study area during the follow-up period. 4. Patients with evidence of cognitive impairment. 5. Patients who do not speak either English or Hindi. 6. Patients who are undergoing treatment for depression at the time of recruitment or who completed treatment within one month prior to recruitment 7. Patients at imminent risk for suicide 8. Patients from households in which another member has been recruited into the study
Where this trial is running
Bhopal, Madhya Pradesh
- Sangath — Bhopal, Madhya Pradesh, India (Recruiting)
Study contacts
- Principal investigator: Vikram Patel, MD — Vikram_Patel@hms.harvard.edu
- Study coordinator: Julia R Pozuelo, PhD
- Email: julia_ruizpozuelo@hms.harvard.edu
- Phone: 617-432-1707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.