Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318539
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : January 21, 2011
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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 Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
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 : December 2003
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00318539

Research Site
Utrecht, Netherlands
Sponsors and Collaborators
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca Identifier: NCT00318539     History of Changes
Other Study ID Numbers: D1441C09907
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Obsessive Compulsive Disorder

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs