obsessive-compulsive disorder OCD
Conditions
Interventions
Treatment will consist of almost daily (4 days/week) rTMS sessions immediately
followed by a 90-minute ERP session. This offers the logistic benefit of
catching up on a missed treatment during a tre
patients who have not reached (partial)
response but feel that they can still profit from continued treatment will also
continue. Patients who worsened during treatment will be discontinued. At the
and it accounts for the slow and linear benefit of repeated
rTMS sessions that has been observed in patients with OCD, who still improve
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the severity of OCD as measured by the Yale-Brown Obsessive-Compulsive Scale I - Y-BOCS I (Goodman et al. 1989). 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 intervention effect will also be reported as a standardized mean difference. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Response (>=35% reduction on Y-BOCS-II) and remission (Y-BOCS-II | — |
Countries
Netherlands
Contacts
Public ContactOA vd Heuvel
Amsterdam UMC
Outcome results
None listed