Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00318539
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Duration (Months): 32
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder	Drug: Quetiapine	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-blind, Placebo-controlled Study
• Study Start Date: Dec 1, 2003
• Actual Study Completion Date: Aug 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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. []

2. 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

1. The onset of response to treatment, using the time to a sustained response as criterion []

2. Side effect profiles, Quality of life, Cognitive functioning []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Utrecht		Netherlands

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: AstraZeneca Netherlands Medical Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00318539
• Other Study ID Numbers: D1441C09907
• First Posted: Apr 27, 2006
• Last Update Posted: Jan 21, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Obsessive Compulsive Disorder
• Additional relevant MeSH terms: Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Quetiapine Fumarate

Study Results

No Results Posted as of Jan 21, 2011