跳至主要内容
临床试验/NL-OMON52013
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

发起方
Amsterdam UMC

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