Clinical Trial: Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-blind, Placebo-controlled Study
Brief Summary:
Quetiapine (Seroquel ®), an atypical antipsychotic registered for use in schizophrenia, which has a very low propensity of extrapyramidal and endocrine side-effects, has also been studied as an adjunct in OCD. In an open trial, ten patients with OCD who had not responded to at least three previous treatments with a SRI at maximum dose and duration were assigned to receive quetiapine in addition to a SRI for 8 weeks. Given the efficacy of quetiapine in treatment resistant patients, and given its rapid onset of action (4-6 weeks), it is postulated that the combination of a low dose atypical antipsychotic and a standard dosage of an SRI as a treatment for patients with OCD might increase the number of responders as well as the effect size.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome:
- The change in Yale Brown obsessive compulsive scale (Y-BOCS) from baseline to week 10 and the number of responders are the primary efficacy parameters.
- Criteria for response will be a 25% or greater change from baseline on the Y-BOCS and a final CGI rating of "much improved or "very much improved".
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The onset of response to treatment, using the time to a sustained response as criterion
- Side effect profiles, Quality of life, Cognitive functioning
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: April 25, 2006
Date Started: December 2003
Date Completion:
Last Updated: January 20, 2011
Last Verified: January 2011
