Transcranial Magnetic Stimulation (TMS) for Patients With Exposure Therapy-resistant Obsessive-compulsive Disorder (OCD): TETRO - a Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam UMC, location VU Medical Center
RECRUITING
Amsterdam
GGZ inGeest
RECRUITING
Amsterdam
Neurocare
NOT_YET_RECRUITING
Eindhoven
Neurocare
NOT_YET_RECRUITING
Groningen
Maastricht UMC+
NOT_YET_RECRUITING
Maastricht
Mondriaan
NOT_YET_RECRUITING
Maastricht
ProPersona
NOT_YET_RECRUITING
Nijmegen
Radboudumc
NOT_YET_RECRUITING
Nijmegen
Contact Information
Primary
Odile A van den Heuvel, MD PhD
oa.vandenheuvel@amsterdamumc.nl
+31-20-4444444
Backup
Tjardo S Postma, MD
tetro@amsterdamumc.nl
+31-20-4444444
Time Frame
Start Date: 2022-05-16
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 250
Treatments
Experimental: real rTMS
verum rTMS condition, 1500 continuous 1-Hz pulses to the pre-SMA
Sham_comparator: sham rTMS
sham rTMS condition, 1500 continuous 1-Hz pulses to the pre-SMA
Related Therapeutic Areas
Sponsors
Collaborators: Mondriaan, Neurocare, Radboud University Medical Center, Maastricht University Medical Center, ProPersona, GGZ inGeest
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov