NCT06153004

OptimizeD Pilot Study

Improving Outcomes in Depression in Primary Care in a Low Resource Setting: Evidence From a Pilot Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Harvard Medical School (HMS and HSDM) · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Detailed description

This pilot study will play a pivotal role in preparation for the forthcoming larger clinical trial, named the OptimizeD study, scheduled for launch in March 2024 (NCT05944926). The primary objective of the OptimizeD study is to explore whether different patients respond differentially to a brief psychological treatment, known as the Healthy Activity Program, or a widely used generic Selective Serotonin Reuptake Inhibitor (fluoxetine). If such differences exist, this study aims to explore whether one can develop a machine learning-generated precision treatment rule to predict the most effective treatment based on individual baseline characteristics. The pilot study has two primary objectives: 1. Evaluate the feasibility and acceptability of the study: This pilot study will focus on assessing the feasibility and acceptability of the research protocol, including recruitment strategies, data collection methods, interventions, and risk management procedures. This evaluation will help refine and tailor the study procedures and play a critical role in setting the stage for the subsequent OptimizeD study. 2. Collect essential outcome data in preparation for the larger trial: This study will test and refine the data instruments, gather initial data on efficacy, and refine the baseline assessment (which will serve as the cornerstone for the development of the precision treatment rule).

Conditions

• Depression
• Depressive Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-03-10
• Completion: 2024-03-31
• First posted: 2023-12-01
• Last updated: 2024-04-09

Locations

1 site across 1 country: India