OptimizeD Pilot Study

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

Conditions

• Depression
• Depressive Disorder

Interventions

BEHAVIORAL

Healthy Activity Program (HAP)

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.

DRUG

Antidepressant medication (ADM)

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Centre for Addiction and Mental Health

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• All India Institute of Medical Sciences, Bhopal

  collaborator OTHER

• Sangath

  collaborator OTHER

• Harvard Medical School (HMS and HSDM)

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2024-03-10

Completion

2024-03-31

Countries

• India

Study Locations