Predicting treatment outcome in obsessive-compulsive disorder using neuroimaging biomarkers

Recruiting

Conditions: Obsessive-compulsive disorder
10002861

Registration Number: NL-OMON45849

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 202

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

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Classifier accuracy as the proportion of patients correctly classified as<br /><br>responder (sensitivity) and non-responder (specificity), differences in the<br /><br>proportion of responders between the randomized (first) and fMRI biomarker<br /><br>allocated (second) cohort, independent network components using resting-state<br /><br>fMRI, structural connectivity using diffusion tensor imaging (DTI), task<br /><br>related activity and connectivity using event-related fMRI, brain volume using<br /><br>structural MRI and cerebral bloodflow using Arterial Spin Labeling (ASL).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Response rate defined as at least a 35% pre-treatment to post-treatment<br /><br>reduction in YBOCS score (Farris et al. 2013), clinical Global<br /><br>Impression-Improvement (CGI-I) score of 1 ('very much improved') or 2 ('much<br /><br>improved').</p><br>