OptimizeD Pilot Study

NCT06153004 | Completed Phase 3 DMC

• 2 other identifiers: IRB20-2144-pilot1R01MH121632-01A1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to explore and refine the trial procedures that will be implemented in a larger-scale clinical trial scheduled to commence in March 2024 (NCT05944926). As part of this study, 60 patients with moderate to severe depression will be randomized to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication. The pilot study has two primary objectives:

1. 1.Evaluate the feasibility and acceptability of the study
2. 2.Collect essential outcome data in preparation for the larger trial

Conditions

Depression; Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• Feasibility as measured by recruitment rate

  The investigators will assess enrolment rate for eligible participants

  3-months

• Feasibility as measured by retention rate

  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

  3-months

• Feasibility of study assessments

  The investigators will examine adherence rates to study procedures and the barriers to study participation reported by participants over the course of the study.

  3-months

• Acceptability of interventions by participants

  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.

  3-months

Secondary Outcomes (1)

• Change from Baseline in Depressive Symptoms

  3-months

Study Arms (2)

Healthy Activity Program (HAP)

EXPERIMENTAL

HAP is a brief psychological treatment adapted from behavioral activation therapy, an empirically supported psychological treatment recommended by the World Health Organization.

Behavioral: Healthy Activity Program (HAP)

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.

Drug: Antidepressant medication (ADM)

Interventions

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.

Healthy Activity Program (HAP)

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.

Antidepressant medication (ADM)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead
• National Institute of Mental Health (NIMH): collaborator
• Harvard School of Public Health (HSPH): collaborator
• Massachusetts General Hospital: collaborator
• Centre for Addiction and Mental Health: collaborator
• Brigham and Women's Hospital: collaborator
• Vanderbilt University: collaborator
• All India Institute of Medical Sciences, Bhopal: collaborator
• Sangath: collaborator

Study Sites (1)

Sangath

Bhopal, Madhya Pradesh, 462016, India

Location

Related Links

• Study description

MeSH Terms

Conditions

Depression; Depressive Disorder

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masked (blinded) field-based assessors will conduct all outcome assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paul Farmer Professor and Chair of the Department of Global Health and Social Medicine

Model Details: Fluoxetine versus a contextually adapted version of behavioral activation called the Healthy Activity Program (HAP) delivered by non-specialists for the treatment of depression

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: August 1, 2023
• Primary Completion: March 10, 2024
• Study Completion: March 31, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available indefinitely or for as long as the NIMH repositories support it.
• Access Criteria: Researchers and interested parties who wish to access the data can submit a formal data access request to the NIMH Data Archive. Researchers who gain access to the data will be required to comply with the data usage policies and guidelines set forth by the NIMH Data Archive.

Locations

IN (1)