Transcranial magnetic stimulation (TMS) for patients with exposure therapy-resistant obsessive-compulsive disorder (OCD): TETRO - a multicenter randomized controlled trial
- Conditions
- obsessieve-compulsieve stoornis (OCS)obsessive-compulsive disorder10002861
- Registration Number
- NL-OMON52013
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
- 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
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method