Status:
RECRUITING
TMS for Exposure Therapy Resistant OCD
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
GGZ inGeest
Radboud University Medical Center
Conditions:
1 Hz Real rTMS to the Pre-SMA
1 Hz Sham rTMS to the Pre-SMA
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
TETRO is a multi-center placebo-controlled double-blind randomized controlled trial with an intervention phase of 5-7 weeks and a follow-up phase of 12 months in 250 adult (18 years and older) OCD pat...
Detailed Description
Rationale: Obsessive-compulsive disorder (OCD) is a serious and disabling mental disorder, characterized by obsessions and compulsions and associated with substantial comorbidity and morbidity (Stein...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05331937
Start Date
May 16 2022
End Date
September 1 2027
Last Update
May 17 2022
Active Locations (8)
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1
Amsterdam UMC, location VU Medical Center
Amsterdam, North Holland, Netherlands, 1081 HZ
2
GGZ inGeest
Amsterdam, Netherlands
3
Neurocare
Eindhoven, Netherlands
4
Neurocare
Groningen, Netherlands