| CTRI Number |
CTRI/2025/11/097100 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Repetitive transcranial magnetic stimulation therapy effectiveness as an add on therapy in depression |
|
Scientific Title of Study
|
Effectiveness of repetitive transcranial magnetic stimulation as an add on therapy in depressive disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIVRAM |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College Safdarjung Hospital |
| Address |
Room no 333
OPD building
Vardhman Mahavir Medical College Safdarjung Hospital
H693 H6W NH 48 near AIIMS Hospital Ansari Nagar West New Delhi 110029
South
DELHI
110029
India |
| Phone |
7009825101 |
| Fax |
|
| Email |
ankushbawa5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manushree Gupta |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi India 110029 |
| Address |
3rd floor Psychiatry OPD
OPD building
Vardhman Mahavir Medical College Safdarjung Hospital
H693 H6W NH 48 near AIIMS Hospital Ansari Nagar West New Delhi 110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
manushree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHIVRAM |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College Safdarjung Hospital |
| Address |
Room no 333
OPD building
Vardhman Mahavir Medical College Safdarjung Hospital
H693 H6W NH 48 near AIIMS Hospital Ansari Nagar West New Delhi 110029
DELHI
110029
India |
| Phone |
7009825101 |
| Fax |
|
| Email |
ankushbawa5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital
NH 48 near AIIMS Hospital Ansari Nagar West New Delhi India 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College Safdarjung Hospital
H693 H6W NH 48 near AIIMS Hospital Ansari Nagar West New Delhi 110029 |
| Type of Sponsor |
Government 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 SHIVRAM |
Vardhman Mahavir Medical College Safdarjung Hospital |
OPD building
Vardhman Mahavir Medical College Safdarjung Hospital
H693 H6W NH 48 near AIIMS Hospital Ansari Nagar West New Delhi 110029
South
DELHI |
7009825101
ankushbawa5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics committee VMMC and SJH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Moderate to severe depressive disorder as per ICD 11 Diagnostic Criteria (MADRS greater than or equal to 20)
Treatment naive or not taking any antidepressant therapy since the last 4 weeks
Individuals who can read and write in either Hindi or English language
|
|
| ExclusionCriteria |
| Details |
Patients with any other neuropsychiatric disorders such as schizophrenia epilepsy dementia and bipolar disorder
Organic diseases leading to depression
Other serious underlying diseases organ dysfunction and malignant tumor comorbidities
History of brain surgery and injury
Patients with High Suicidal Risk based on clinical assessment
Contraindications to medication and treatment methods in this study such as ferromagnetic implants in the head a history of neurosurgical operations or a pacemaker implant medication that lower the threshold of epileptic seizures (eg Clozapine Pethidine Aminophylline)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in depressive symptom severity as measured by the Montgomery–Asberg Depression Rating Scale (MADRS) |
Baseline
At 4 weeks and at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in cognitive function, as measured by the Montreal Cognitive Assessment (MoCA) + Trail Making Test (TMT) + Stroop Test |
Baseline measurement before giving rTMS and follow up measurement at 2 weeks and 4 weeks after giving rTMS. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
13/11/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
This study is a randomized controlled trial evaluating the effectiveness of repetitive transcranial magnetic stimulation therapy in patients with depressive disorder. The intervention group will receive active repetitive transcranial magnetic stimulation (10 Hz over the left dorsolateral prefrontal cortex) alongside standard SSRI/SNRI medication, while the control group will receive sham repetitive transcranial magnetic stimulation with medication. The primary objective is to assess changes in depressive symptoms using the Montgomery–Asberg Depression Rating Scale (MADRS), with secondary outcomes measuring cognitive improvements via the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), and Stroop Test. The study will include 70 participants (35 per group) aged 18–65 with moderate to severe depression, excluding those with neuropsychiatric comorbidities or contraindications to repetitive transcranial magnetic stimulation. Ethical approval has been obtained, and informed consent will be secured from all participants. The trial will run for 18 months, with follow-ups at 2 and 4 weeks post-intervention. Statistical analysis will compare outcomes between groups to determine repetitive transcranial magnetic stimulation efficacy in treating depression and enhancing cognitive function. |