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Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study
This study has been completed.
Study NCT00318539   Information provided by AstraZeneca
First Received: April 25, 2006   Last Updated: March 24, 2009   History of Changes

April 25, 2006
March 24, 2009
December 2003
 
  • 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".
Same as current
Complete list of historical versions of study NCT00318539 on ClinicalTrials.gov Archive Site
  • The onset of response to treatment, using the time to a sustained response as criterion
  • Side effect profiles, Quality of life, Cognitive functioning
Same as current
 
Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study
Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-Blind, Placebo-Controlled Study

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.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Obsessive Compulsive Disorder
Drug: Quetiapine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
90
August 2006
 

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00318539
 
D1441C09907
AstraZeneca
 
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP