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 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
Dr Saikumar Reddy M
Asha Neuromodulation Clinics
