Obsessive-compulsive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: * Diagnosis of obsessive compulsive disorder (OCD) according to the DSM-IV * 18-70 years of age * Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements
Exclusion criteria
Exclusion criteria: * Bipolar disorder, current or past psychosis, primary alcohol or drug abuse * Contraindication for MRI such as metal implants, claustrophobia, left-handedness and pregnancy * Major head trauma or neurological disease, current or in history * Adequate treatment of OCD with high dosed SSRI or CBT at the moment of screening or within 4 weeks before screening * Current treatment with tricyclic antidepressant or antipsychotic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Classifier accuracy as the proportion of patients correctly classified as responder (sensitivity) and non-responder (specificity), differences in the proportion of responders between the randomized (first) and fMRI biomarker allocated (second) cohort, independent network components using resting-state fMRI, structural connectivity using diffusion tensor imaging (DTI), task related activity and connectivity using event-related fMRI, brain volume using structural MRI and cerebral bloodflow using Arterial Spin Labeling (ASL). | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate defined as at least a 35% pre-treatment to post-treatment reduction in YBOCS score (Farris et al. 2013), clinical Global Impression-Improvement (CGI-I) score of 1 ('very much improved') or 2 ('much improved'). | — |
Countries
Netherlands