| 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
|
|
|
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
|
|
|
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. |