跳至主要内容
临床试验/CTRI/2026/03/106628
CTRI/2026/03/106628招募中不适用

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 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2026年4月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
189
试验地点
1
主要终点
Change in the absolute Yale Brown Obsessive Compulsive Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 86.00 Year(s)(—)
性别
All

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

Change in the absolute Yale Brown Obsessive Compulsive Scale

时间窗: Day 1, Day 5, Day 30, Day 90, Day 180

次要结局

  • 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)

研究者

发起方
Investigator Initiated Trial
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Saikumar Reddy M

Asha Neuromodulation Clinics

研究点 (1)

Loading locations...

相似试验