FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/04/108659 [Registered on: 20/04/2026] Trial Registered Prospectively
Last Modified On: 18/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Neuromodulation technique (rTMS)]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   High Frequency Repetitive Transcranial Magnetic Stimulation In The Management Of Treatment Resistant Depression Cases. 
Scientific Title of Study   To determine efficacy High Frequency Repetitive Transcranial magnetic Stimulation In The Management Of Treatment Resistant Depression A Single Blind Randomised Sham Controlled Study From North Karnataka 
Trial Acronym  HF-rTMS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rachana 
Designation  Junior Resident 1, MD Psychiatry  
Affiliation  Karnataka Medical College And Research Institute Hubballi  
Address  Psychiatry Department,KMCRI Vidyanagar,Hubballi

Dharwad
KARNATAKA
580021
India 
Phone  9901418592  
Fax    
Email  rachnamaiya2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr ArunKumar C 
Designation  Professor and Head Of Department  
Affiliation  Karnataka Medical College And Research Institute Hubballi  
Address  Department of Psychiatry KMCRI Vidyanagar Hubballi

Dharwad
KARNATAKA
580021
India 
Phone  9448122277  
Fax    
Email  arunkumarsavitha@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr ArunKumar C 
Designation  Professor and Head Of Department  
Affiliation  Karnataka Medical College And Research Institute Hubballi  
Address  Department of Psychiatry KMCRI Vidyanagar,Hubballi

Dharwad
KARNATAKA
580021
India 
Phone  9448122277  
Fax    
Email  arunkumarsavitha@hotmail.com  
 
Source of Monetary or Material Support  
Karnataka Medical College And Research Institute, Vidyanagar,KMCRI, Hubballi - 580021, Karnataka, India.  
 
Primary Sponsor  
Name  Dr Rachana Maiya 
Address  Psychiatry Department, KMCRI,Vidyanagar, Hubballi-580021, Karnataka, India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rachana  Karnataka Medical College and Research Institute Hubballi   Psychiatry Department OPD No.15, Room no.1 KMCRI,Vidyanagar Hubballi-580021
Dharwad
KARNATAKA 		 09901418592

rachnamaiya2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Karnataka Medical College and Research Institute Hubballi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE   NOT APPLICABLE  
Intervention  rTMS  Sham Controlled trial to assess efficacy of HF-rTMS for treatment resistant depression cases.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients willing and able to give written informed consent coming to psychiatry OPD screened using PHQ9 with score more than equal to 10 , current depressive episode, without psychotic features , satisfying operational definition of treatment resistant depression failed to respond atleast 2 adequate trials of antidepressants for duration of 4-6 weeks , preferably from 2 different pharmacological classes ,with confirmed treatment adherence response of less than 50% reduction in symptoms  
 
ExclusionCriteria 
Details  Refuse consent for study ,who underwent other neuromodulation like ECT , who is substance disorder except nicotine use disorder , medical comorbidity such as epilepsy, vascular,traumatic ,tumors ,infectious or metabolic lesion , pregnancy,implanted ferromagnetic device ,associated with psychosis  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of High frequency Repetitive Transcranial Magnetic Stimulation in the management of treatment resistant depression in terms of response to intervention   Over period of 12 months from time of study 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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 2 
Date of First Enrollment (India)   16/06/2028 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rachnamaiya2000@gmail.com].

  6. For how long will this data be available start date provided 09-04-2026 and end date provided 13-04-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   To assess the efficacy of High Frequency Repetitive Transcranial Magnetic Stimulation in treatment resistant depression is single blind randomised sham Controlled trial with eligible,consented , adults of 18-65years with treatment resistant depression ( Operational definition According to Ruhe and colleague) satisfying all inclusion and exclusion criteria ( excluding pregnancy, substance use disorder except nicotine use disorder, epilepsy, vascular,brain lesions , psychosis, implanted ferromagnetic device or ones who had ECT excluded ) are recruited,with sample size of 56  participants randomised in a 1:1 ratio to active rTMS(modified accelerated intermittent theta bursts stimulation at 600 pulses/ session over 3-10 minutes 3 pulses at frequency of 50 hertz every 200 msec with motor threshold of 90% ,2sessions / day with minimum gap of 45 minutes for 10 days ,total 20 session ,at left DLPFC. Using standard localising technique)  or sham rTMS ( clicking sounds / tapping without delivery of magnetic stimulation) using fixed block randomisation,with allocation concealment sequentially numbered ,sealed opaque envelopes , participants and outcome assessors are blinded and treatment provider is not blinded , to intervention, ,primary outcome to assess treatment response using Montgomery Asberg Depression Rating scale baseline end of 10 days ,4th week and 8 th week of treatment and study period is over duration of  12 months. 
Close