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CTRI Number  CTRI/2026/04/108005 [Registered on: 09/04/2026] Trial Registered Prospectively
Last Modified On: 30/03/2026
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   Evaluating Repetitive Transcranial Magnetic Stimulation as an add-on treatment for Obsessive-Compulsive Disorder 
Scientific Title of Study   Effectiveness of Repetitive Transcranial Magnetic Stimulation augmentation of pharmacotherapy in Obsessive Compulsive 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  Somya Tuteja 
Designation  Post Graduate Junior Resident 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Psychiatry, Level 5, D Block, Government Medical College and Hospital, Sector-32, Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  8198884524  
Fax    
Email  somtutj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivangi Mehta 
Designation  Assistant Professor  
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Psychiatry, Level 5, D Block, Government Medical College and Hospital, Sector-32, Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  9855784512  
Fax    
Email  shivangi02@gmail.com  
 
Details of Contact Person
Public Query  
Name  Somya Tuteja 
Designation  Post Graduate Junior Resident 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Psychiatry, Level 5, D Block, Government Medical College and Hospital, Sector-32, Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  8198884524  
Fax    
Email  somtutj@gmail.com  
 
Source of Monetary or Material Support  
Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Chandigarh, India 160030 
 
Primary Sponsor  
Name  Government Medical College and Hospital 
Address  Department of Psychiatry, Level 5, D block, Government Medical College and Hospital, Chandigarh, India 160030 
Type of Sponsor  Government 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 Somya Tuteja  Government Medical College and Hospital, Chandigarh  Level 4, B block, Government Medical College and Hospital, Chandigarh
Chandigarh
CHANDIGARH 		 8198884524

somtutj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GMCH, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F422||Mixed obsessional thoughts and acts,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Repetitive Transcranial Magnetic Stimulation  Participants in the intervention arm will receive low-frequency rTMS sessions over the supplementary motor area (SMA) at standard, safety-approved frequencies and intensities, administered five days per week for four weeks in addition to pharmacotherapy. 
Comparator Agent  Sham Repetitive Transcranial Magnetic Stimulation   The control arm will receive sham controlled rTMS sessions (using a sham coil mimicking sound and scalp sensations without effective stimulation) for the same schedule along with pharmacotherapy.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 to 55 years.
2. Diagnosis of Obsessive Compulsive Disorder (OCD) as per ICD-11 criteria.
3. Baseline Yale–Brown Obsessive Compulsive Scale (Y-BOCS) score more than or equal to 16 (moderate severity or above).
4. On standard pharmacological treatment (SSRI or clomipramine with or without augmentation with low-dose antipsychotic).
5. Willingness to comply with study procedures and follow-up.
 
 
ExclusionCriteria 
Details  1. History of epilepsy, seizures, or significant neurological disorder (e.g., stroke, brain tumour, head injury with loss of consciousness).
2. Presence of metallic implants, pacemaker, cochlear implants, or other contraindications to rTMS.
3. Current comorbid psychotic disorder, bipolar disorder, severe personality disorder, suicidal ideation or recent suicide attempt.
4. Active substance use disorder within the past 6 months, patients currently using Benzodiazepines.
5. Severe or uncontrolled medical illnesses (e.g., cardiovascular disease, uncontrolled hypertension, thyroid disorder).
6. Pregnancy or lactation.
7. Patients who have previously received ECT or rTMS treatment for OCD in the previous 6 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of active Repetitive Transcranial Magnetic Stimulation with standard pharmacotherapy versus sham Repetitive Transcranial Magnetic Stimulation with standard pharmacotherapy in persons with Obsessive–Compulsive Disorder.   Baseline assessments will be conducted prior to randomization, followed by weekly assessments during the treatment phase and follow-up assessments at 10- and 16-weeks post-baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   10/04/2026 
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 Yet Recruiting 
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  

This study aims to evaluate whether repetitive transcranial magnetic stimulation (rTMS), when added to ongoing standard pharmacotherapy, is more effective than sham rTMS plus pharmacotherapy in reducing the symptoms of obsessive-compulsive disorder (OCD). OCD is a chronic and disabling psychiatric condition characterized by intrusive thoughts (obsessions) and repetitive behaviors (compulsions). Many patients continue to experience significant symptoms despite receiving recommended medications. In this study, 74 patients aged 18 to 55 years, diagnosed with OCD, will be recruited from the outpatient and inpatient services of the Department of Psychiatry, Government Medical College and Hospital (GMCH-32), and Mental Health Institute (MHI). After baseline assessments, participants will be randomly assigned to one of two groups: active rTMS with standard pharmacotherapy or sham rTMS with standard pharmacotherapy. Active rTMS involves the delivery of magnetic pulses over the supplementary motor area to modulate specific brain circuits implicated in OCD. The sham procedure appears identical in setup and sound but does not deliver active magnetic stimulation. Both groups will receive scheduled sessions five days per week for four weeks. Participants will be evaluated at baseline, at the end of the fourth week, and at 10 and 16 weeks using standardized rating scales including the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression (CGI) scale, and Montreal Cognitive Assessment (MoCA). Medication adherence and any adverse effects will be monitored regularly throughout the study period. This study seeks to determine whether augmentation with rTMS results in greater and faster improvement in OCD symptoms and overall functioning compared to pharmacotherapy alone.

 
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