| CTRI Number |
CTRI/2024/10/074777 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate the Effectiveness of Repetitive Transcranial Magnetic Stimulation rTMS in augmenting patients with Treatment Resistant Depression |
|
Scientific Title of Study
|
Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS )as an augmenting agent in Treatment Resistant Depression |
| Trial Acronym |
rTMSTRD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishav Rakesh Damathia |
| Designation |
Psychiatry Resident |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital |
| Address |
Room no 2, Department of Psychiatry, Centre of Excellence in Mental Health, ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7838879095 |
| Fax |
|
| Email |
vrdamathia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautam Sharma |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital |
| Address |
Room no 2, Department of Psychiatry, Centre of Excellence in Mental Health, ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9313231020 |
| Fax |
|
| Email |
gautamsharma@dr.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishav Rakesh Damathia |
| Designation |
Psychiatry Resident |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital |
| Address |
Room no 2, Department of Psychiatry, Centre of Excellence in Mental Health, ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7838879095 |
| Fax |
|
| Email |
vrdamathia@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. RML Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Vishav Rakesh Damathia |
ABVIMS and Dr. RML Hospital |
Room no 3, Department of Psychiatry, Centre of Excellence in Mental Health, ABVIMS and Dr. RML Hospital, New Delhi
New Delhi
DELHI |
7838879095
vrdamathia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, ABVIMS and Dr. RML Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (2) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
repetitive Transcranial Magnetic Stimulation
rTMS |
10Hz (120% MT)
C3
40 pulses, 75 trains, inter-train interval 11 over 19 min
10 sessions over 2 weeks |
| Comparator Agent |
Sham group |
non rTMS arm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
no response to two antidepressant trials of six weeks each
criteria for depression
hamd score of more than eight |
|
| ExclusionCriteria |
| Details |
Psychotic Disorder
Epilepsy
Substance Abuse
Metal Implants
Pregnancy
Recent Brain Surgery or Psychosurgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in scores of HAMD/HDRS, MADRS over 4 weeks |
2 and 4 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in scores of PSQI and MOCA over 4 weeks |
2 and 4 weeks post intervention |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/10/2024 |
| 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="0"
Months="6"
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
|
The study will be conducted at the Department of Psychiatry, CEIMH, ABVIMS, and Dr. RML Hospital, New Delhi. It is designed as a prospective interventional study, focusing on patients with depression secondary to chronic medical illness. Following ethical clearance, participants aged 18-65 who met DSM-5 criteria for depression, had HAM-D scores greater than 8, and were resistant to two antidepressant trials were recruited. Exclusion criteria were comorbid psychotic disorders, epilepsy, substance abuse, metal implants, pregnancy, and recent brain stimulation or psychosurgery. Eligible participants, who met the inclusion criteria, were informed about the study’s purpose, duration, and potential benefits and risks. No compensation was provided. Informed consent was obtained using an Ethics Committee-approved form, with relatives encouraged to participate for comprehensive data collection. Consenting subjects and their unaffected relatives will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS), HAM-D, PSQI, and MoCA. rTMS sessions will be conducted over two weeks, with 10 sessions targeting the left dorsolateral prefrontal cortex (F3). Depression, cognitive impairment, and sleep quality were evaluated at baseline, two weeks post-treatment, and four weeks post-treatment. Participants were fully informed about the rTMS procedure and shown an educational video. Data were analyzed and compared after the study’s completion.
previous similaCTRI registered studies CTRI/2018/02/011890 CTRi/2024/01/061590 |