Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

Phase 2

Completed

• Conditions: Obsessive Compulsive Disorder

• Registration Number: NCT00318539
• Lead Sponsor: AstraZeneca

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 Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2006-04-25
• Study First Submitted QC: 2006-04-25
• Study First Posted: 2006-04-27
• Study Completion: 2006-08
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• All patients meet the DSM IV criteria for obsessive-compulsive disorder
• Y-BOCS score > 16 if obsessions and compulsions
• Y-BOCS score > 10 if only obsessions
• Y-BOCS score > 10 if only compulsions
• Male and female, aged between 18-70 years
• Female patients of childbearing potential must have a negative pregnancy test and use a reliable method of contraception.
• Written informed consent

Exclusion Criteria

• Presence of any of the following DSM IV conditions; major depression (with a HDRS>15, [17 item]), bipolar disorder, schizophrenia or any other psychotic condition, tic disorder, substance related disorder during the past 6 months, epilepsy, or any structural CNS disorder or stroke within the last year.
• Evidence of clinically significant and unstable cardiovascular, gastro-intestinal, pulmonary, renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within the past year, or micturition abnormalities
• Patients at risk for suicide
• Multiple serious drug allergies or known allergy for the trial compounds
• Use of antipsychotics during 6 months before the screening visit
• Use of any other psychotropic drug during 6 months before the screening visit
• Cognitive and behavioural treatment 3 months prior to the screening visit
• Any known contra-indication against citalopram or quetiapine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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".

Secondary Outcome Measures

Name	Time	Method
The onset of response to treatment, using the time to a sustained response as criterion
Side effect profiles, Quality of life, Cognitive functioning

Trial Locations

Locations (1)

Research Site; 🇳🇱 Utrecht, Netherlands