OptimizeD

Overview

India bears a significant portion, 50 million, of the global 258 million depression cases, a leading cause of disability. The Global Burden of Disease Study highlights its immense impact, with 917 DALYs per 100,000 annually, persisting since 1990. An alarming treatment gap of 83% exacerbates India's mental health crisis, especially in states like Madhya Pradesh, where depression prevalence is 4.18%. A randomized control trial integrating Health Activity Program and antidepressant medication, alongside genomic insights, offers promise. By understanding individual characteristics, a precision treatment approach aims to bridge the gap and offer hope amidst adversity.

Rationale

The OptimizeD study aims to improve outcomes in depression in primary care in India. As part of this study, we will randomize 1500 patients with moderate to severe depression to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine). The main objective of the OptimizeD study is to determine whether different patients respond differentially to HAP or fluoxetine and, if so, whether we can optimize outcomes in a cost-effective fashion for primary care patients with moderate to severe depression.

Progress till date

• The pilot, conducted from July 2023 to December 2023 across 8 PHCs in Bhopal, Madhya Pradesh, recruited 78 patients. 

  
  

• A five-day meeting, held from January 19th to 23rd, 2024 gathered study collaborators from Harvard Medical School, AIIMS Bhopal, Sangath Bhopal, Vanderbilt University, and the University of Toronto. This pivotal gathering focused on solidifying study procedures, including technical aspects, study designs, and site selection, ensuring comprehensive preparation for the forthcoming Main Trial. The genomic, HAP, ADM, and Economic aspects were discussed at length.

  
  

• The Main trial started on 18th March 2024.

Partner/s

• Harvard Medical School, Boston, USA

• National Institute of Mental Health, USA