Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Antidepressant medication · 2 trials · 2 indications
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.
The investigators will assess enrolment rate for eligible participants
The investigators will evaluate retention rates, which are calculated as the ratio of patients who complete the study to the total number of patients enrolled
The investigators will examine adherence rates to study procedures and the barriers to study participation reported by participants over the course of the study.
The investigators will assess treatment compliance. For the HAP arm, this will be defined as having completed at least six sessions. For the ADM arm, this will be defined as having completed more than 80% of the recommended 12-week course of antidepressant medication.
| 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. |
| Antidepressant medication (ADM) | 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). |
| Antidepressant medication (ADM) | DRUG | Patients assigned to antidepressant medication will start on fluoxetine 20 mg/day which 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. Patients who cannot tolerate fluoxetine will be switched to escitalopram. |
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 ...