OptimizeD Pilot Study

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06153004
• Other study ID #: IRB20-2144-pilot
• Secondary ID: 1R01MH121632-01A
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Harvard Medical School (HMS and HSDM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 31, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
India	Sangath	Bhopal	Madhya Pradesh

Sponsors (9)

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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as measured by recruitment rate	The investigators will assess enrolment rate for eligible participants	3-months
Primary	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
Primary	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
Primary	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	Change from Baseline in Depressive Symptoms	The investigators will measure depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report scale to screen for symptoms of depression. 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.	3-months

External Links

•   Study description