TMS for Exposure Therapy Resistant OCD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
repetitive transcranial magnetic stimulation (rTMS)
Combination productrTMS (real versus sham) is used as adjuvant to ERP
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: real rTMSExperimental treatment 1 intervention
Group B: sham rTMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Y-BOCS
The severity of OCD as measured by the Yale-Brown Obsessive-Compulsive Scale Y-BOCS I
Time frame
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.Secondary outcomes
1
response and remission
response: ≥35% reduction on Y-BOCS \| remission: Y-BOCS≤12
Time frame
baseline (T0) versus directly post-treatment (5, 6 or 7 weeks post-baseline, dependent on duration of treatment) + 3, 6 and 12 months follow-up2
Standard Mean Difference (SMD) on the Clinical Global Impression (CGI) severity scale
global functioning
Time frame
baseline (T0) versus directly post-treatment (5, 6 or 7 weeks post-baseline, dependent on duration of treatment) + 3, 6 and 12 months follow-up3
Clinical Global Impression (CGI) improvement scale
global improvement
Time frame
baseline (T0) versus directly post-treatment (5, 6 or 7 weeks post-baseline, dependent on duration of treatment) + 3, 6 and 12 months follow-up4
Quality of life (EQ-5D-5L)
quality of life
Time frame
baseline (T0) versus directly post-treatment (5, 6 or 7 weeks post-baseline, dependent on duration of treatment) + 3, 6 and 12 months follow-upOther outcomes
1
tic severity, measured using the Yale Global Tic Severity Scale (YGTSS)
tic severity (only in OCD patients with comorbid tics)
Time frame
baseline (T0) versus directly post-treatment (5, 6 or 7 weeks post-baseline, dependent on duration of treatment) + 3, 6 and 12 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Amsterdam UMC, location VUmc
Lead sponsor
GGZ inGeest
Collaborator
Radboud University Medical Center
Collaborator
ProPersona
Collaborator
Maastricht University Medical Center
Collaborator
Mondriaan
Collaborator
Neurocare
Collaborator
Source ClinicalTrials.gov