Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00318539

Purpose

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	Intervention	Phase
Obsessive Compulsive Disorder	Drug: Quetiapine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-Blind, Placebo-Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	90
Study Start Date:	December 2003
Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318539

Locations

Netherlands
Research Site
Utrecht, Netherlands

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Netherlands Medical Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D1441C09907
Study First Received:	April 25, 2006
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00318539 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

Obsessive Compulsive Disorder

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions

Quetiapine
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Central Nervous System Agents
Obsessive-Compulsive Disorder

ClinicalTrials.gov processed this record on November 09, 2009