Skip to main content
Clinical Trials/CTRI/2026/03/106628
CTRI/2026/03/106628RecruitingNot Applicable

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)

Investigator Initiated Trial1 site in 1 country189 target enrollmentStarted: April 1, 2026Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
189
Locations
1
Primary Endpoint
Change in the absolute Yale Brown Obsessive Compulsive Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 86.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients and their legally accepted relatives who provide consent to participate in the study.
  • Diagnosis of OCD as per ICD
  • Patients whose YBOCS is at or above
  • Patients on any previous medication for OCD will be shifted to SSRI-only regimen after one week wash-out period prior to recruiting.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Change in the absolute Yale Brown Obsessive Compulsive Scale

Time Frame: Day 1, Day 5, Day 30, Day 90, Day 180

Secondary Outcomes

  • 1. Clinical Global Impression (CGI)
  • 2. World Health Organization Disability Assessment Schedule (WHODAS) 2.0(Day 1, Day 5, Day 30, Day 90, Day 180)

Investigators

Sponsor
Investigator Initiated Trial
Sponsor Class
Private hospital/clinic
Responsible Party
Principal Investigator
Principal Investigator

Dr Saikumar Reddy M

Asha Neuromodulation Clinics

Study Sites (1)

Loading locations...

Similar Trials