NL-OMON52013招募中不适用
Transcranial magnetic stimulation (TMS) for patients with exposure therapy-resistant obsessive-compulsive disorder (OCD): TETRO - a multicenter randomized controlled trial - TETRO
Amsterdam UMC0 个研究点目标入组 250 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- OCD as current primary diagnosis
- •- Age 18 and older
- •- Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of 16 or higher.
- •- Insufficient response to state-of-the art exposure therapy with response
- •prevention (ERP) and/or drop-out from ERP due to extreme anxiety/avoidance
- •- The following comorbid disorders are allowed (as long as OCD is the current
- •primary diagnosis): depression, other anxiety disorders, ADHD, tic/Tourette*s
- •disorder, eating disorders, personality disorders, autism spectrum disorder
- •(when this does not dominate the clinical profile, i.e. is not main diagnosis).
- •- Commitment to actively undergo intensive exposure therapy (both supervised
- •during ERP sessions, as well as unsupervised at home)
- •- Unmedicated (for at least 8 weeks) or stable dosage of psychotropic
- •medication (for at least 8 weeks), involving serotonergic antidepressants
- •(SSRI, SNRI, clomipramine). Other psychotropic medication that is allowed
- •(provided dosage is stably established for at least 8 weeks): methylphenidate,
- •mood stabilizers, antipsychotic drugs
- •- Ability to participate in frequent treatment sessions (4 days/week, for 5 (or
- •6, or 7) weeks) at one of the 5 sites nearest to their home and/or work
- •- Ability to participate in pre-treatment MRI session (for neuronavigation) at
- •one of the 3 academic sites nearest to their home and/or work
- •- Capacity for providing informed consent
排除标准
- •- OCD patients with hoarding as main symptom dimension
- •- The following comorbid disorders (current diagnosis) are not allowed:
- •psychotic disorders, bipolar disorder, autism spectrum disorder (when this
- •dominates the clinical profile, i.e. is diagnosed as main disorder), substance
- •use disorder
- •- Active suicidal thoughts and intent to act on it
- •- Chronic use of benzodiazepines is not allowed
- •- Cochlear implant
- •- (History of) epilepsy
- •- Pregnancy
- •- Extreme claustrophobia or metallic objects in or on the body, preventing from
- •participation in MRI session
- •- Space-occupying lesion on MRI
- •- Previous rTMS treatment (for blinding reasons)
研究者
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