| CTRI Number |
CTRI/2025/11/097524 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A follow-up study to explore the effects of Escitalopram treatment on the process of ageing and related disorders in individuals with Major Depressive Disorder (MDD) |
|
Scientific Title of Study
|
Study on the Role of Senescence and Neurodegenerative Biomarkers in Major Depressive Disorder subject during Escitalopram treatment |
| 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 Neelam Yeram |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Biomedical Sciences, Navi Mumbai |
| Address |
Department of Biochemistry, MGM School of Biomedical Sciences, MGMIHS, Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
08454016003 |
| Fax |
|
| Email |
neelamyeram21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Yeram |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Biomedical Sciences, Navi Mumbai |
| Address |
Department of Biochemistry, MGM School of Biomedical Sciences, MGMIHS, Navi Mumbai
MAHARASHTRA
410209
India |
| Phone |
08454016003 |
| Fax |
|
| Email |
neelamyeram21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam Yeram |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Biomedical Sciences, Navi Mumbai |
| Address |
Department of Biochemistry, MGM School of Biomedical Sciences, MGMIHS, Navi Mumbai
MAHARASHTRA
410209
India |
| Phone |
08454016003 |
| Fax |
|
| Email |
neelamyeram21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research (ICMR-DHR), Ministry of Health and Family Welfare, Government of India |
| MGM Institute of Health Sciences, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr. Neelam Yeram |
| Address |
Department of Biochemistry, MGM School of Biomedical Sciences, MGMIHS, Navi Mumbai |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mansee Thakur |
Department of Biotechnology, MGM School of Biomedical Sciences, MGMIHS, Navi Mumbai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neelam Yeram |
MGM School of Biomedical Sciences, MGM IHS, Navi Mumbai |
Department of Medical Biochemistry
Raigarh
MAHARASHTRA |
08454016003
neelamyeram21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Biomedical and Allied Health Research Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, (2) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Escitalopram |
10 mg OD, Oral for 6 months |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals diagnosed with Major Depressive Disorder based on structured clinical questionnaire as per DSM 5 criteria (American Psychiatric Association, 2013) and prescribed for Escitalopram treatment by Psychiatrists will be included in the study.
2. Individuals of both sexes in the age group of 18 to 35 years will be included.
3. Individuals willing to participate in the study will be included. |
|
| ExclusionCriteria |
| Details |
1. Individuals suffering from Head injury, cerebral stroke, dementia, chronic diabetes, poisoning, schizophrenia, chronic alcoholism or any other severe mental illness and disease affecting brain except Depression will be excluded from the study.
2. The individuals not willing to participate in the study were excluded from the study.
3. Individuals having the last 2 months history of drug treatment with significant central serotonergic effects or any investigational treatment for MDD will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Variations in the Neurodegenerative and Senescence Blood Biomarkers in MDD Subjects undergoing Escitalopram treatment |
At 0, 3 and 6 months interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expressions of Ras p21, p16 and p53 genes in blood |
At 0, 3 and 6 months interval |
| Senescence associated beta galactosidase activity in blood |
At 0, 3 and 6 months interval |
| Serum levels of beta amyloid peptide, Tau protein, neurofilament light and Glial fibrillary acidic protein |
At 0, 3 and 6 months interval |
| Gene expression of serotonin receptor 2A, apolipoprotein E and amyloid precursor protein in blood |
At 0, 3 and 6 months interval |
| Blood levels of Cortisol, Serotonin and Homocysteine |
At 0, 3 and 6 months interval |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
09/12/2025 |
| 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="3"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to neelamyeram21@gmail.com
- For how long will this data be available start date provided 09-12-2029 and end date provided 09-12-2034?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a non-randomized single arm observational follow up study in which 65 subjects diagnosed with Major Depressive Disorder (single episode / recurrent) prescribed for Escitalopram treatment (10 mg OD, Oral) will be recruited. The participants will be recruited based on the inclusion and exclusion criteria. The study will be conducted at MGM School of Biomedical Sciences, Navi Mumbai. The study has been approved by the Institutional Ethics Committee. Informed consent will be obtained from each participant and their legal representative or family member. The blood samples of the study participants will be evaluated for the levels of senescence and neurodegeneration biomarkers at Baseline (before treatment starts), 3 months interval and 6 months interval. The results obtained for 3 months and 6 months will be compared with the results of baseline data for interpretation. |