| CTRI Number |
CTRI/2026/03/105210 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two probiotic supplements given along with escitalopram in patients with major depression. |
|
Scientific Title of Study
|
Comparing efficacy of two probiotic strains as an adjunctive therapy to escitalopram in major
depressive disorder at tertiary healthcare centre: A Randomized Controlled 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 |
Dr Amisha Rathee |
| Designation |
Postgraduate Student 1st year |
| Affiliation |
Maharaja Agrasen Medical College, Agroha |
| Address |
Department of Pharmacology, Maharaja Agrasen Medical College, Agroha
Hisar
HARYANA
125047
India |
| Phone |
8059018088 |
| Fax |
|
| Email |
amisharathee888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amisha Rathee, Dr Shalini Virani, Dr Palak Talwar |
| Designation |
Postgraduate Student 1st year; Professor, Associate Professor |
| Affiliation |
Maharaja Agrasen Medical College, Agroha |
| Address |
Department of Pharmacology, Maharaja Agrasen Medical College, Agroha
Hisar
HARYANA
125047
India |
| Phone |
8059018088 |
| Fax |
|
| Email |
amisharathee888@gmail.com, shalinivirani@mamc.edu.in, palatalwar@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amisha Rathee |
| Designation |
Postgraduate Student 1st year |
| Affiliation |
Maharaja Agrasen Medical College, Agroha |
| Address |
Department of Pharmacology, Maharaja Agrasen Medical College, Agroha
Hisar
HARYANA
125047
India |
| Phone |
8059018088 |
| Fax |
|
| Email |
amisharathee888@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaja Agrasen Medical College, Agroha, Hisar- 125047, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Maharaja Agrasen Medical College, Agroha, Hisar -125047, Haryana, India |
| Type of Sponsor |
Other [Government-aided Medical College] |
|
|
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 Amisha Rathee |
Maharaja Agrasen Medical College |
Department of Psychiatry Room Number 62
Hisar
HARYANA |
8059018088
amisharathee888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F334||Major depressive disorder, recurrent, in remission, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm 1
Escitalopram 20 mg + Lactobacillus rhamnosus
|
Intervention Description:
Tab. Escitalopram 20 mg orally once daily (baseline dose; may be tapered up to 5 mg based on clinical response and HAM-D scoring) + probiotic sachet containing Lactobacillus rhamnosus administered orally once daily for 8 weeks.
Duration of Intervention:
8 weeks
Route of Administration:
Oral
|
| Comparator Agent |
ARM 2 Escitalopram 20 mg + Bacillus coagulans |
Arm 2 Intervention Name: Escitalopram + Bacillus coagulans Type of Intervention: Drug Intervention Description: Tab. Escitalopram 20 mg orally once daily (baseline dose; may be tapered up to 5 mg based on clinical response and HAM-D scoring) + probiotic sachet containing Bacillus coagulans administered orally once daily for 8 weeks. Duration of Intervention: 8 weeks Route of Administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients newly diagnosed with major depressive disorder as per DSM-V criteria.
2 Sex/Age: -Either sex from 18 –55 years of age.
3. Patients willing to participate and comply with the follow-up visits and study
procedures.
4. Patients who will give informed written consent.
5. HAM-D assessment score of more than 10 will be included. |
|
| ExclusionCriteria |
| Details |
1. Patient already on any other antidepressant, antipsychotic or probiotic
supplementation.
2. Past history of any substance abuse by the patient
3. Pregnant women
4. Intellectual disable and developmental delay patients
5. Patients with comorbidities like hypertension, uncontrolled diabetes, coronary
artery disease, gastrointestinal disorders and any other organic disorder
6. All those who report any serious adverse drug reaction during the course of
study will be treated accordingly and will be excluded from the study and will be
analyzed separately |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity of depressive symptoms as assessed by change in HAM-D score. |
Baseline (Day 0), 2 weeks, 4 weeks, 6 weeks, and 8 weeks (final assessment at 8 weeks). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of safety by monitoring adverse drug reactions (ADRs) associated with probiotic strains and escitalopram using the Naranjo ADR Probability Scale. |
At baseline and at 2nd week, 4th week, 6th week, and 8th week follow-up visits. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Major Depressive Disorder (MDD) is a common psychiatric illness with significant morbidity. Emerging evidence suggests that modulation of the gut–brain axis through probiotics may have beneficial effects on depressive symptoms. This study aims to compare the efficacy and safety of two probiotic strains, Lactobacillus rhamnosus and Bacillus coagulans, as adjunctive therapy to escitalopram in adult patients (18–55 years) newly diagnosed with MDD.This is a randomized, parallel-group, triple-blind, active-controlled clinical trial to be conducted at a tertiary care center. A total of 128 participants will be randomly allocated into two groups: one group will receive escitalopram plus Lactobacillus rhamnosus, and the other will receive escitalopram plus Bacillus coagulans, for a duration of 8 weeks.
The primary outcome will be change in Hamilton Depression Rating Scale (HAM-D) score from baseline to 8 weeks. The secondary outcome will include assessment of adverse drug reactions using the Naranjo ADR Probability Scale.
The study aims to identify the more effective probiotic strain as an adjunct to standard antidepressant therapy and evaluate its safety profile. |