| CTRI Number |
CTRI/2025/07/090830 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study done to find out the effect of depression on immunity by assessing immune status parameters at the start and after twelve weeks of antidepressant treatment |
|
Scientific Title of Study
|
Cytotoxic T-cell exhaustion before and after twelve weeks trial of antidepressant treatment in first-onset major depressive disorder |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shanty G Raj |
| Designation |
Post graduate Resident - 1 |
| Affiliation |
Delhi university |
| Address |
room no: 206
second floor
pathology block
maulana azad medical college
New Delhi
DELHI
110002
India |
| Phone |
9567759248 |
| Fax |
|
| Email |
shantyraj11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bidhan Chandra Koner |
| Designation |
Director professor |
| Affiliation |
delhi university |
| Address |
Room no: 211
Second floor
Department of Biochemistry
pathology block
maulana azad medical college
New Delhi
DELHI
110002
India |
| Phone |
9968604229 |
| Fax |
|
| Email |
bckoner@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima Kapoor |
| Designation |
Associate professor |
| Affiliation |
delhi university |
| Address |
sixth floor
Department of Psychiatry
G.I.P.M.E.R
New Delhi
DELHI
110002
India |
| Phone |
9718592498 |
| Fax |
|
| Email |
mahimamalhotra22@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical college
Bahadur Shah Zafar Marg,
near Delhi Gate,
Balmiki Basti
New Delhi
110002 |
|
|
Primary Sponsor
|
| Name |
Dr Shanty G Raj |
| Address |
Room No: 206
department of biochemistry
Second floor pathology block
Maulana Azad Medical college
110002 |
| Type of Sponsor |
Other [Myself] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shanty G Raj |
G.I.P.M.E.R |
Psychiatry OPD and ward 2
Ground floor
GB PANTT hospital
1, Jawaharlal Nehru Marg, 64 Khamba
New Delhi
DELHI |
9567759248
shantyraj11@gmail.com |
| Dr Shanty G Raj |
Maulana azad medical college |
medical research unit
3rd floor academic block
2, Bahadur Shah Zafar Marg, near Delhi Gate
Balmiki Basti
New Delhi
DELHI |
9567759248
shantyraj11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL (Lok Nayak,G.B.Pant Institute of postgraduate medical education(GIPMER) and research Hospital,Guru Nanak Eye Centre,New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F32||Major depressive disorder, singleepisode, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NILL |
NILL |
| Intervention |
NILL |
NILL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients of either gender aged between 18-60 years, who will attend psychiatry OPD or be admitted to psychiatry IPD with the diagnosis of first onset major depressive disorder (MDD) without psychotic symptoms according to ICD-11 criteria will be selected as MDD cases |
|
| ExclusionCriteria |
| Details |
1. Any other psychiatric disorder
2. Substance use
3. Acute and chronic major physical illness
4. Any chronic medications except iron with folic
acid and calcium with vitamin D supplementation
5. History of any infection during the last 6
weeks.
6. Electroconvulsive therapy or any other
neuromodulation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PD-1 cell counts |
ONE YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CTLA 4 CELL COUNTS
TNF- ALPHA, IFN-GAMMA
TREATMNET RESPONSE/TREATMENT RESISNTANT DEPRESSION
|
ONE YEAR |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
25/07/2025 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shantyraj11@gmail.com].
- For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Major depressive disorder is a mood disorder with variable severity The pathophysiology of depression has not yet been clearly defined Various hypotheses stated that various neurochemical changes happen in the brain during depression These substances might influence the immune system Both humoral and cell-mediated immunity are altered in depression As Major depressive disorder is a chronic stressful state the T Cells get exhausted The exhaustion is mediated by various proteins like Programmed cell death protein PD 1 and Cytotoxic T Lymphocyte antigen CTLA 4 Exhaustion of these cytotoxic T lymphocytes leads to depressed cell mediated immunity by decreased production of cytokines like TNF alpha and IFN gamma The diagnostic prognostic and predictive role in the therapeutic outcome of T cell exhaustion has not yet been clearly explored Hence the present study is designed to explore the above mentioned aspects |