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CTRI Number  CTRI/2025/02/079953 [Registered on: 04/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Clinical Trial to Study the Effect of Probiotics Combined with Antidepressants on Indian Patients with Major Depressive Disorder 
Scientific Title of Study   Effect of Probiotics as an Addon to Standard Antidepressant Therapy in Patients of Major Depressive Disorder in Indian population A Randomized Double Blind Placebo Controlled Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun P Sunder 
Designation  Senior Resident Doctor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room No. 4022, Department of Pharmacology, 4th Floor, Teaching Block, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  8289858183  
Fax    
Email  drarunpsunder@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  KH Reeta 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room No. 4029, Department of Pharmacology, 4th Floor, Teaching Block, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9711204141  
Fax    
Email  reetakh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arun P Sunder 
Designation  Senior Resident Doctor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room No. 4022, Department of Pharmacology, 4th Floor, Teaching Block, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  8289858183  
Fax    
Email  drarunpsunder@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi,Ansari Nagar,110029,India  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  All India Institute of Medical Sciences New Delhi Ansari Nagar, 110029 India  
Type of Sponsor  Research institution and hospital 
 
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 Arun P Sunder  All India Institute of Medical Sciences New Delhi  Department of Psychiatry, All India Institute of Medical Sciences , New Delhi
New Delhi
DELHI 
8289858183

drarunpsunder@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES, ANSARI NAGAR, NEW DELHI 110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Glucose capsule of identical shape and size will be given once daily in the morning empty stomach for 6 weeks 
Intervention  Probiotic capsule containing 120 million spores of lactic acid bacillus  Probiotic capsule containing 120 million spores of lactic acid bacillus will be given once daily in the morning empty stomach for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All adult patients of either sex aged 18-65 years with clinical diagnosis of Major
Depressive Disorder as per DSM-5 criteria.

Patients on stable dose (no change in dose) of anti-depressants for 4 weeks.

Patients willing to participate and give consent. 
 
ExclusionCriteria 
Details  Patients with comorbid psychiatric or neurological disorders and substance use disorder
except nicotine replacement therapy

Patient currently having suicidal ideas or history of suicidal plan/attempt.

Patients who have taken antibiotics in the last 4 weeks, are currently on antibiotics, or
need to take antibiotics during the study period

Pregnancy or lactation or expecting to get pregnant during the treatment.

Patient on concomitant warfarin, antiplatelets, chemotherapy for oncologic conditions,
steroids, having autoimmune diseases, immunocompromised patients, short-gut
syndrome.

Patients with chronic liver disease.

Patient not willing to give consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in depression symptoms as assessed by Hamilton Depression Rating Scale (HAMD-17)  0 and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the change in serum IDO and serum BDNF after 6 weeks of add-on
probiotic therapy.

To evaluate the change in cognition score and the Montgomery-Ã…sberg Depression
Rating Scale (MADRS) after 6 weeks of add-on probiotic therapy.

To evaluate the safety of add-on probiotic therapy. 
0 AND 6 WEEKS 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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   N/A 
Date of First Enrollment (India)   14/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study will use a prospective, randomized, double-blind, placebo-controlled design to investigate the effects of probiotic (lactic acid bacillus) supplementation over 6 weeks on patients with major depressive disorder (MDD). The primary aim is to assess changes in depressive symptoms using the Hamilton Depression Rating Scale (HAMD-17). Secondary objectives include evaluating changes in serum IDO and serum BDNF levels, cognitive scores, and the Montgomery-Ã…sberg Depression Rating Scale (MADRS), as well as assessing the safety of the supplementation. 

Participants will be clinically diagnosed with major depressive disorder and must have been on stable antidepressant therapy for at least the past 4 weeks. They will be screened in the psychiatry outpatient department at AIIMS, New Delhi. Eligible participants meeting the inclusion criteria will be randomly assigned to either the treatment group, receiving probiotic (lactic acid bacillus) supplementation, or the placebo group, receiving a matching placebo. Both groups will continue their ongoing antidepressant regimen for 6 weeks. 

At enrollment, demographic data, depression scores, and antidepressant treatment-related data will be collected. Blood samples will be taken to measure depression-related markers (BDNF and IDO). After 6 weeks of supplementation, all baseline parameters will be reassessed. Changes in depression scores from baseline to post-supplementation will be calculated and presented as mean (SD). Any adverse events during the intervention will be monitored and reported to the corresponding authorities.

 
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