Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Phase 3

TMS for Exposure Therapy Resistant OCD

NCT05331937 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 3
Started
2022-05-16
Last updated
2026-03-04

Condition(s) studied

1 Hz Real rTMS to the Pre-SMA1 Hz Sham rTMS to the Pre-SMA

Investigational drug(s) / intervention(s)

repetitive transcranial magnetic stimulation (rTMS)

repetitive transcranial magnetic stimulation (rTMS): rTMS (real versus sham) is used as adjuvant to ERP

Study 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 patients who show no/insufficient response to ERP, aiming to establish the cost-effectiveness of low frequency (1 Hz) rTMS to the pre-SMA (compared to sham rTMS to the pre-SMA) as adjuvant treatment to exposure with response prevention (ERP). The treatment consists of 4 times/week rTMS combined with ERP for at least 5 weeks (20 sessions), with optional extension phase of 1 or 2 weeks (maximum of 28 sessions in total).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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)

Primary outcome measure(s)

  • Y-BOCS — The primary endpoint is the difference between the active and sham intervention groups in post-treatment severity of OCD, estimated using an ANCOVA model that adjusts for pre-treatment severity of OCD.
    The severity of OCD as measured by the Yale-Brown Obsessive-Compulsive Scale Y-BOCS I

Trial sites (8)

FacilityCityRegionStatus
Amsterdam UMC, location VU Medical Center Amsterdam North Holland Recruiting
GGZ inGeest Amsterdam Netherlands Recruiting
Neurocare Eindhoven Netherlands Not Yet Recruiting
Neurocare Groningen Netherlands Not Yet Recruiting
Maastricht UMC+ Maastricht Netherlands Not Yet Recruiting
Mondriaan Maastricht Netherlands Not Yet Recruiting
ProPersona Nijmegen Netherlands Not Yet Recruiting
Radboudumc Nijmegen Netherlands Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05331937 on ClinicalTrials.gov ↗ ← All trials in the Netherlands