| CTRI Number |
CTRI/2026/03/106628 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Behavioral
Other (Specify) [TMS Treatment] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Novel 5-day High Intensity Treatment for OCD patients using Deep Transcranial Magnetic Stimulation and intensive ERP therapy |
|
Scientific Title of Study
|
Long-term Outcomes in Obsessive-Compulsive Disorder Patients Receiving Three Different Modalities of Treatment: SSRIs, Accelerated Deep Transcranial Magnetic Stimulation (aDTMS) with SSRIs, and High Intensity Treatment (HIT) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saikumar Reddy M |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Asha Neuromodulation Clinics |
| Address |
FF7, 4th Floor, Fantasy Square, Near Biodiversity Park, Gachibowli, Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8008299666 |
| Fax |
|
| Email |
drmsreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saikumar Reddy M |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Asha Neuromodulation Clinics |
| Address |
FF7, 4th Floor, Fantasy Square, Near Biodiversity Park, Gachibowli, Hyderabad
TELANGANA
500032
India |
| Phone |
8008299666 |
| Fax |
|
| Email |
drmsreddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswin Kumar M |
| Designation |
Academic Head |
| Affiliation |
Asha Neuromodulation Clinics |
| Address |
FF7, 4th Floor, Fantasy Square, Near Biodiversity Park, Gachibowli, Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8985681201 |
| Fax |
|
| Email |
akartik1985@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Investigator Initiated Trial |
| Address |
FF7, 4th Floor, Fantasy Square, Near Biodiversity Park, Gachibowli, Hyderabad |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Aswin Kumar M |
Asha Neuromodulation Clinics, Gachibowli |
HIT for OCD, Room # FF7, 4th Floor, Fantasy Square, Near Biodiversity Park, Gachibowli, Hyderabad
Hyderabad
TELANGANA |
08985681201
akartik1985@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Asha Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Arm 1: SSRIs alone |
Standard daily dosages of SSRIs not exceeding as mentioned below:
1. Escitalopram 20-80 mg or
2. Fluoxetine 20-120 mg
3. Clonazepam 1 mg or
4. Lorazepam 2 mg
|
| Comparator Agent |
Arm 2: SSRIs + aDTMS
|
Group description: Standard doses of SSRIs + 5-day aDTMS with H7 coil
Accelerated Deep TMS (aDTMS) using H7 coil; 75 trains of 2s and 20Hz with 14s ITI given at 100% of foot RMT; 3000 pulses/session; 4 sessions per day for 5 days; total 20 sessions |
| Intervention |
Arm 3: HIT group |
Group description: Standard doses of SSRIs + 30 hours of concentrated ERP spread over in 5 days + aDTMS given as 20 sessions in 5-day initial phase and 24 maintenance sessions over next 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
86.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients and their legally accepted relatives who provide consent to participate in the study.
b. Diagnosis of OCD as per ICD10.
c. Patients whose YBOCS is at or above 14.
d. Patients on any previous medication for OCD will be shifted to SSRI-only regimen after one week wash-out period prior to recruiting.
|
|
| ExclusionCriteria |
| Details |
a. Nonconsenting patients or their relatives
b. Patients with significant suicidality
c. Patients with substance dependence and substance withdrawal symptoms
d. Pregnant women
e. Patients declared ‘unfit’ after screening for electromagnetic field compatibility
f. Patients with severe and unstable medical comorbidities.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the absolute Yale Brown Obsessive Compulsive Scale |
Day 1, Day 5, Day 30, Day 90, Day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Clinical Global Impression (CGI)
|
Day 1, Day 5, Day 30, Day 90, Day 180 |
| 2. World Health Organization Disability Assessment Schedule (WHODAS) 2.0 |
Day 1, Day 5, Day 30, Day 90, Day 180 |
|
|
Target Sample Size
|
Total Sample Size="189"
Sample Size from India="189"
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)
|
01/04/2026 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
prospective study is designed to evaluate the clinical efficacy of a novel High
Intensity Treatment (HIT) developed by ANC, for the treatment of OCD. HIT is a
combination of pharmacotherapy using Selective Serotonin Reuptake Inhibitors
(SSRIs) + accelerated Deep TMS (aDTMS) + concentrated Exposure and Response
Prevention (cERP) treatment offered as 5-day intensive phase followed by
6-month follow-up phase. Comparison of outcomes will be performed across three
study groups. Group 1- patients on SSRIs alone; group 2- patients on 5-day aDTMS
+ SSRIs; group 3- patients receiving HIT. The difference in Yale Brown
Obsessive Compulsive Scale (YBOCS) will be the primary outcome measure in all
groups, taken at day 5, day 30, 3-month and 6-month follow-up. BrainsWay’s H7
coil will be used for aDTMS administered over 5 days. Adverse effects will be
documented after each day of treatment in groups 2 and 3. Secondary outcome
measures like Clinical Global Impression-Severity (CGI-S) and WHODAS 2.0 will
also be administered. |