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CTRI Number  CTRI/2024/06/069487 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Randomized Assessor Blinded Academic Trial to Assess Role of Probiotics as Adjuvant Antidepressants 
Scientific Title of Study   Clinical Outcome of Probiotics as Adjuvant Antidepressant an Assessor Blinded Randomised Academic Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aaryaman Chatterjee 
Designation  PG Student  
Affiliation  Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health 
Address  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Department of Psychiatry P.O: Tezpur, Dist: Sonitpur (Assam)

Sonitpur
ASSAM
784001
India 
Phone    
Fax    
Email  chatterjeeaaryaman@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijay Gogoi  
Designation  Associate Professor 
Affiliation  Lokopriypo Gopinath Bordoloi Regional Institute of Mental Health  
Address  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Dept of Psychiatry, P.O: Tezpur, Dist: Sonitpur (Assam)

Sonitpur
ASSAM
784001
India 
Phone  8135848178  
Fax    
Email  vijaygogoi50@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aaryaman Chatterjee 
Designation  PG Student 
Affiliation  Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health 
Address  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health P.O: Tezpur, Dist: Sonitpur (Assam)

Sonitpur
ASSAM
784001
India 
Phone  8420890629  
Fax    
Email  chatterjeeaaryaman@gmail.com  
 
Source of Monetary or Material Support  
Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health,P.O :Tezpur,District:Sonitpur(Assam),PIN: 784001 
 
Primary Sponsor  
Name  Aaryaman Chatterjee  
Address  21/A TOLLYUNGE ROAD , KOLKATA -700026 
Type of Sponsor  Other [Self ] 
 
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 Aaryaman Chatterjee  Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health   Kalibari Main Road Mahabhairab Tezpur -784001 Dept of Psychiatry, Out Patient Department, Room No. 20
Sonitpur
ASSAM 
08420890629

chatterjeeaaryaman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G||Mental Health,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Probiotics   VIZYLAC GG : Containing Lactobacillus Rhamnosus GG (ATCC 53103); 6 Billion CFU per capsule;1 Capsule to given once daily for 30 days SPORLAC PLUS: Each capsule containing not less than 2.5 BILLION CELLS EACH OF LACTOBACILLUS ACIDOPHILLUS (R0052) LACTOBACILLUS RHAMNOSUS(R0011) BIFIDOBACTERIUM LONGUM (R00175) SACCHAROMYCES BOULARDII BACILLUS COAGULARIS;1 Capsule to be given once daily for 30 days  
Comparator Agent  Tab Escitalopram 10 mg  1 Tablet Escitalopram 10 mg to be given once daily for 30 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Drug naive/ Relapse with a minimum of 3 months without medication
Prescribed T Escitalopram
 
 
ExclusionCriteria 
Details  Taking Antibiotics currently or in the last 1 month
History of acute or chronic inflammatory conditions
Antidepressants other than Escitalopram
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the clinical outcome in patients receiving only anti depressants, SSPs plus antidepressants , MSP plus anti depressant
To compare effect of probiotics on each symptom dimension of Depression 
1 MONTH 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the change in level of inflammatory markers (CRP) after 1 month   1 MONTH 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/07/2024 
Date of Study Completion (India) 22/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

:               Depression is a common debilitating illness impacting more than 280 million people worldwide. It impacts all age groups across all socioeconomic strata and has been designated as a major contributor to the global disability burden. As highlighted by the National Mental Health Survey of India 2015-16, the treatment gap for any mental morbidity stands at around 70-90%. Among those who receive treatment, approximately one-fourth of the patients fail to respond to antidepressants. Despite advances in neurosciences, no single theory can adequately explain the onset and progression of Depression. The broad consensus links MDD with impairment in neural signalling, loss of hippocampal volume, reduction in growth factors such as BDNF, loss of synaptic plasticity and cognitive functions, decline in monoamine neurohormones, and dysregulation of polyamine metabolism. In recent years, the gut microbiota has emerged as a potential player in the pathogenesis of MDD, with evidence suggesting an intricate relationship between gut bacteria and Depression.

To the best of our knowledge no studies have been done in India so far    determining the clinical outcome in patients receiving only single species probiotic and multiple species probiotic along with antidepressants and comparing  the change in levels of inflammatory markers 
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