Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

Obsessive Compulsive Disorder Clinical Trial

Official title:

Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318539
• Other study ID #: D1441C09907
• Status: Completed
• Phase: Phase 2
• First received: April 25, 2006
• Last updated: January 20, 2011
• Start date: December 2003
• Est. completion date: August 2006

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• Quetiapine

Locations

Country	Name	City	State
Netherlands	Research Site	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	The onset of response to treatment, using the time to a sustained response as criterion
Secondary	Side effect profiles, Quality of life, Cognitive functioning