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
Dr Saikumar Reddy M
Asha Neuromodulation Clinics
研究点 (1)
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