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CTRI Number  CTRI/2025/09/094384 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 05/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Magnetic Stimulation as an add on treatment for Depression. 
Scientific Title of Study   Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) as an adjuvant for Severe Depression  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amrutha Gudimetla 
Designation  Postgraduate 
Affiliation  NRI Academy of Sciences 
Address  Department of Psychiatry NRI Academy of Sciences Chinakakani Mangalagiri Guntur

Guntur
ANDHRA PRADESH
522503
India 
Phone  9492969820  
Fax    
Email  amruthagudimetla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. T V Pavan Kumar 
Designation  Professor and HOD 
Affiliation  NRI Academy of Sciences 
Address  Department of Psychiatry NRI Academy of Sciences Chinakakani Mangalagiri Guntur, INDIA - 522503
Department of Psychiatry NRI Academy of Sciences Chinakakani Mangalagiri Guntur - 522503
Guntur
ANDHRA PRADESH
522503
India 
Phone  9849220263  
Fax    
Email  dr.tvpavi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amrutha Gudimetla 
Designation  Postgraduate 
Affiliation  NRI Academy of Sciences 
Address  Department of Psychiatry NRI Academy of Sciences Chinakakani Mangalagiri Guntur


ANDHRA PRADESH
522503
India 
Phone  9492969820  
Fax    
Email  amruthagudimetla@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  NRI Academy of Sciences 
Address  NRI Academy of Sciences Chinakakani Mangalagiri Guntur, INDIA - 522503 
Type of Sponsor  Private medical college 
 
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 AMRUTHA GUDIMETLA  NRI GENERAL HOSPITAL  Department of Psychiatry NRI Academy of Sciences Chinakakani
Guntur
ANDHRA PRADESH 		 9492969820

amruthagudimetla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE - NRIMC & GH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Repetitive Transcranial Magnetic Stimulation  A total of 15 sessions (on a daily basis) of rTMS will be delivered over a period of three weeks following the uniform treatment protocol as described below. Target of Interest: – Left Dorsolateral Prefrontal Cortex Coil Placement – Over the F3 electrode position using the International 10-20 EEG method. Duration of therapy: 30 minutes/session Sessions: 15 sessions over a period of 2 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Right Handed patients
2.Of Ages 18-60 Years, Of Both Sexes,
3.Who Are Diagnosed With Severe Depression According To ICD 11. 
 
ExclusionCriteria 
Details  1. Medical commodities that need immediate attention
2. Any contraindication to rTMS such as any metallic implants in close contact to coil, cochlear implants
3. Any other psychiatric co morbidity

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) as an adjuvant in Severe Depression.  After 10 rTMS sessions 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the number of rTMS sessions required to bring
about a response (less than 50% scores) in the identified patients in HDRS. 		 After every 2 rTMS sessions 
To assess the improvement of functional capacity of the patients using GAF scale with rTMS.  Before and after 10 rTMS sessions 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   17/09/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   rTMS is an emerging treatment for depression, particularly when administered to the left dorsal prefrontal cortex for an antidepressant effect. Clinical evidence suggests that rTMS is effective when administered during a depressive episode in patients. However, there is a lack of published data on the role of rTMS in depression from India, possibly due to limited availability of the facility in mental health centers. Clinical data from hospital settings can help bridge the gap between RCTs and the actual effects of rTMS in typical practice settings. Therefore, this study is aimed at assessing the effectiveness of rTMS as an adjuvant in treating severe depression in our hospital setting. 
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