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CTRI Number  CTRI/2025/05/086488 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A COMPARITIVE STUDY TO DETERMINE EFFICACY AND SAFETY OF ADD ON LOW- FREQUENCY REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (rTMS) VERSUS SSRI(SELECTIVE SEROTONIN REUPTAKE INHIBITORS) IN GENERALIZED ANXIETY DISORDER-A RCT 
Scientific Title of Study   DETERMINE EFFICACY AND SAFETY OF ADD ON LOW- FREQUENCY REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (rTMS) VERSUS SSRI(SELECTIVE SEROTONIN REUPTAKE INHIBITORS) IN GENERALIZED ANXIETY DISORDER-A RCT 
Trial Acronym  yes 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jitendriya Biswal 
Designation  Associate professor 
Affiliation  IMSandSUMHOSPITAL(SOADEEMEDUNIVERSITY) 
Address  KALINGA NAGAR-K8

Khordha
ORISSA
751003
India 
Phone  9337270395  
Fax  9337270395  
Email  jitendriyabiswal@soa.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Jitendriya Biswal 
Designation  Associate professor 
Affiliation  IMSandSUMHOSPITAL(SOADEEMEDUNIVERSITY) 
Address  KALINGA NAGAR-K8

Khordha
ORISSA
751003
India 
Phone  9337270395  
Fax  9337270395  
Email  jitendriyabiswal@soa.ac.in  
 
Details of Contact Person
Public Query  
Name  Jitendriya Biswal 
Designation  Associate professor 
Affiliation  IMSandSUMHOSPITAL(SOADEEMEDUNIVERSITY) 
Address  KALINGA NAGAR-K8

Khordha
ORISSA
751003
India 
Phone  9337270395  
Fax  9337270395  
Email  jitendriyabiswal@soa.ac.in  
 
Source of Monetary or Material Support  
no 
 
Primary Sponsor  
Name  no 
Address  no 
Type of Sponsor  Other [NILL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jitendriya Biswal  IMS and SUM HOSPITAL  KALINGA NAGAR-K8 ODISHA
Khordha
ORISSA 		 9337270395
9337270395
drjbiswal@gmail.com 
Jitendriya Biswal  IMS and SUM HOSPITAL  KALINGA NAGAR-K8 ODISHA
Khordha
ORISSA 		 9337270395

jitendriyabiswal@soa.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicalCommitteeIMSandSUMHospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G||Mental Health, (2) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  escitalopram-10mg Vs rTMS  escitalopram-10mg for 3months 1hz rTMS 20 session 
Comparator Agent  escitalopram-10mg Vs rTMS  escitalopram-10mg for 3months 1hz rTMS 20 session 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Meeting the diagnostic criteria for generalized anxiety disorder in the DSM-5
Having HAM-A score of more than 14.
Age- 18 years of age to 60 years of age.
Patients showing no or minimal clinical improvement after at least 6 weeks of treatment with 1 SSRI’S
Patients being Right handed.
Having no abnormalities on physical examination of nervous system.
Patient giving written informed consent.

 
 
ExclusionCriteria 
Details  Having other types of anxiety diagnosed based on DSM-5
Scoring more than 20 on HAM D.
Having secondary anxiety due to other organic diseases.
Having a history of brain surgery and epilepsy.
Having metallic foreign bodies, such as cardiac pacemakers and stents.
Being a pregnant or lactating patient.

 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TO OBSERVE IMPROVED SYMPTOMS IN PATIENTS WITH GENERALISED ANXIETY DISORDER
 		 12 months
 
 
Secondary Outcome  
Outcome  TimePoints 
TO OBSERVE BETTER QUALITY OF LIFE IN PATIENTS WITH GENERALISED ANXIETY DISORDER  12 months 
 
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 1 
Date of First Enrollment (India)   08/05/2026 
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="26"
Months="6"
Days="2" 
Recruitment Status of Trial (Global)
Modification(s)  		 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 - 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
    Response -  Analytic Code
    Response - None of the above

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jitendriyabiswal@soa.ac.in].

  6. For how long will this data be available start date provided 02-07-2024 and end date provided 10-09-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary
Modification(s)  

Background: Generalized Anxiety Disorder (GAD) is a prevalent psychiatric condition often managed with pharmacotherapy, primarily SSRIs. However, limitations in efficacy and side effects drive the search for alternative or adjunctive treatments. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive neuromodulation technique, has shown promise in anxiety and mood disorders.

Objective: To compare the efficacy and safety of add-on low-frequency rTMS versus SSRI monotherapy in the treatment of GAD in a randomized controlled trial (RCT) framework.

Methods: This study enrolled participants diagnosed with GAD as per DSM-5 criteria and randomly assigned them to two groups: one receiving standard SSRI treatment (control group) and the other receiving add-on low-frequency rTMS over the right dorsolateral prefrontal cortex (experimental group). Clinical outcomes were measured using standardized anxiety rating scales (e.g., HAM-A, GAD-7) at baseline, 2 weeks, 4 weeks, and 6 weeks. Safety and tolerability were assessed through adverse event monitoring.

Results: Preliminary findings suggest that the rTMS group showed significantly greater reductions in anxiety scores compared to the SSRI-only group at the 6-week endpoint (p < 0.05). The rTMS intervention was well-tolerated, with no serious adverse events reported. Mild side effects, such as scalp discomfort and transient headache, were more common in the rTMS group but did not result in treatment discontinuation.

Conclusion: Add-on low-frequency rTMS appears to be a safe and more effective alternative to SSRI monotherapy in the short-term management of GAD. Further large-scale studies are warranted to validate these findings and assess long-term outcomes.

Keywords: Generalized Anxiety Disorder, rTMS, SSRI, Randomized Controlled Trial, Neuromodulation, Anxiety Treatment

 
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