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CTRI Number  CTRI/2024/01/061932 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Improving outcomes in Depression in Primary Care in a Low resource setting 
Scientific Title of Study   Improving outcomes in Depression in Primary Care in a Low resource setting 
Trial Acronym  OptimizeD study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikram Patel 
Designation  Professor 
Affiliation  Harvard University and Sangath 
Address  Sangath Goa H No 451 168, Bhatkar Waddo, Socorro, Bardez, Porvorim, Goa
Department of Global Health and Social Medicine, Harvard Medical School 641 Huntington Avenue Boston, Massachusetts, USA
North Goa
GOA
403501
India 
Phone  -617-432-1707  
Fax    
Email  Vikram_Patel@hms.harvard.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Anant Bhan 
Designation  Site-Principal Investigator 
Affiliation  Sangath-Bhopal 
Address  Plot No. 106, Good Shepherd Colony, Danish Kunj, Kolar Rd, Bhopal, Madhya Pradesh

Bhopal
MADHYA PRADESH
462042
India 
Phone  7554936506  
Fax    
Email  anant.bhan@sangath.in  
 
Details of Contact Person
Public Query  
Name  Dr. Anant Bhan 
Designation  Site-Principal Investigator 
Affiliation  Sangath-Bhopal 
Address  Plot No. 106, Good Shepherd Colony, Danish Kunj, Kolar Rd, Bhopal, Madhya Pradesh

Bhopal
MADHYA PRADESH
462042
India 
Phone  7554936506  
Fax    
Email  anant.bhan@sangath.in  
 
Source of Monetary or Material Support  
National Institute of Mental Health (NIMH) Office of Science Policy, Planning, and Communications 6001 Executive Boulevard, Room 6200, MSC 9663 Bethesda, MD 20892-9663 
 
Primary Sponsor  
Name  Harvard University 
Address  Harvard Medical School 641 Huntington Avenue Boston, Massachusetts 02115 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anant Bhan  Sangath-Bhopal  Plot No. 106, Good Shepherd Colony, Danish Kunj, Kolar Rd, Bhopal, Madhya Pradesh 462042
Bhopal
MADHYA PRADESH 		 7554936506

anant.bhan@sangath.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
AIIMS Bhopal  Approved 
Harvard University IRB  Approved 
Sangath IRB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Antidepressant medication (fluoxetine)   Fluoxetine is one of the safest medications used to treat depression and treatment, and it is a routinely used medication and part of the Essential Drug List (EDL) in India. Participants in the ADM arm will receive fluoxetine for the first 3 months of the study and then be assessed for remittance. Participants will start on fluoxetine 20 mg/day and can be raised to 40 mg/day at week 3 or 6 for patients who have yet to remit. Participants who remit will continue on fluoxetine for the remaining 9 months of the study (12 months in total). Participants who do not remit or remit and then subsequently relapse will be referred to specialty care. If a participant experiences a serious side effect as a result of taking fluoxetine, they will be referred to specialist care and discontinued from the medication. 
Intervention  Healthy Activity Program (HAP)  HAP is a brief psychological treatment adapted from behavioral activation therapy, an empirically supported psychological treatment recommended by WHO. HAP, delivered 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. Participants will receive between 6 to 8 counseling (individual) sessions during a period of 12 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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).  
 
ExclusionCriteria 
Details  - 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 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Depressive symptoms: measured by the Patient Health Questionnaire-9 (PHQ-9)   Baseline (week 0), during acute treatment (week 1, 2, 3, 6), primary endpoint (week 12), & follow-up assessments (6-, 9-, 12-month) 
 
Secondary Outcome  
Outcome  TimePoints 
Generalized Anxiety Disorder Assessment (GAD-7)
 		 Baseline, 3 months, 6 months, 9 months, 12 months 
WHO Disability Assessment Schedule II (WHODAS-II)  Baseline, 3 months, 6 months, 9 months, 12 months 
Minimal Clinically Important Difference (MCID)  3 months 
World Health Organization Well-Being Index (WHO-5)
 		 Baseline, 3 months, 6 months, 9 months, 12 months 
Client Sociodemographic & Service Receipt Inventory (CSSRI)  Baseline, 3 months, 6 months, 9 months, 12 months 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included nda.nih.gov).

  6. For how long will this data be available start date provided 30-12-2026 and end date provided 30-12-3000?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

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 objective of OptimizeD is to generate a precision treatment rule (PTR) for predicting which patient will respond better to either of the two monotherapies in routine primary care. 

 
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