Clinical trial NCT00318539: Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study
Official title: Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive Compulsive Disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
measure: 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 outcomes:
measure: The onset of response to treatment, using the time to a sustained response as criterion
measure: Side effect profiles, Quality of life, Cognitive functioning
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Netherlands Medical Director, MD
role: STUDY_DIRECTOR
References: