Status:
COMPLETED
OptimizeD Pilot Study
Lead Sponsor:
Harvard Medical School (HMS and HSDM)
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Harvard School of Public Health (HSPH)
Conditions:
Depression
Depressive Disorder
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06153004
Start Date
August 1 2023
End Date
March 31 2024
Last Update
April 9 2024
Active Locations (1)
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1
Sangath
Bhopal, Madhya Pradesh, India, 462016