Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05944926 | Improving Outcomes in Depression in Primary Care in a Low Resource Setting | PHASE3 | RECRUITING | 1,500 | — | — | Mar 18, 2024 | Mar 31, 2027 | Nov 5, 2025 | 1 | India |
Remission is defined as PHQ-9 total score \< 5. The PHQ-9 is a self-report measure of depressive symptoms in the prior 2 weeks. Items are rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27, where higher scores indicate more severe depressive symptoms. We will dichotomised the total score using the cut-off score of 5.
| Arm | Type | Description |
|---|---|---|
| Healthy Activity Program (HAP) | EXPERIMENTAL | HAP is a brief psychological treatment adapted from behavioral activation therapy, an empirically supported psychological treatment recommended by WHO. |
| Antidepressant medication (fluoxetine) | EXPERIMENTAL | Fluoxetine is a selective serotonin reuptake inhibitors (SSRIs) and one of the safest medications used to treat depression. It is a routinely used medication and part of the Essential Drug List (EDL) in India. |
| Name | Type | Description |
|---|---|---|
| Healthy Activity Program (HAP) | BEHAVIORAL | 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. |
| Antidepressant medication (fluoxetine) | DRUG | 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). |
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 ...