| 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
|
|
|
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
|
|
|
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 |