Pharmacological enhancement of fear extinction in OCD; a randomized placebo controlled, double blind study.

Phase 2

Conditions: Obsessive Compulsive Disorder

Registration Number: NL-OMON33819

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- All patients meet the DSM-IV criteria for OCD
- Y-Bocs score: * 18 if obsessions and compulsions; * 12 if only obsessions or compulsions
- Male and female, aged between 18-70 years
- Female patients of childbearing potential must have a negative pregnancy test and use reliable method of contraception.
- Written informed consent
- Eligible for exposure therapy

Exclusion Criteria

- Presence of any of the following DSM IV conditions:
* Major depression (HDRS * 15)
* Bipolar Disorder
* Schizophrenia or any other psychotic disorder
* Tic disorder
* Substance related disorder during the past 6 months
* Epilepsy or any structural CNS disorder of stroke within the last year;- Presence of primary or co-morbid personality disorder
- Evidence of clinically significant and unstable cardiovascular, gastrointestinal, pulmonary, Renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within de past year or micturition abnormalities.
- Currently taking benzodiazepines
- Patients at risk for suicide
- Multiple serious drug allergies of known allergy for DCS
- Inability to speak Dutch or English

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in Yale Brown Obsessive Compulsive Scale (Y-BOCS), time of onset of<br /><br>change on the Y-BOCS and time of administering DCS (directly pre- or post ERP).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>VLGT : Verbal Learning and Memory Test<br /><br>WCST: Wisconsin Card Sorting Test<br /><br>TOL: Tower of London<br /><br>ET: Extinction Task<br /><br>CGI: Clinical Global Impression scale<br /><br>BABS: Brown Assessment of Belief Scale<br /><br>HDRS: Hamilton Depression Rating Scale<br /><br>HARS: Hamilton Anxiety Rating Scale<br /><br>SDS: Sheehan Disability Scales<br /><br>WHOQOL World Health Organization Quality of Life<br /><br>FSEC Fawcett side effects checklist<br /><br>Tic-P: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness</p><br>