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CompletedNCT00318539Updated Jan 21, 2011

Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

A Phase 2 interventional study of Quetiapine in Obsessive Compulsive Disorder, sponsored by AstraZeneca. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-01-21.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obsessive Compulsive Disorder

Keywords

  • Obsessive Compulsive Disorder
03

In context

Compulsive Personality Disorder

367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.

This study's enrollment of 90 is above the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.

Browse Compulsive Personality Disorder studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
90 participants

Interventions

  • DrugQuetiapine
06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Research Site
    Utrecht, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00318539
Lead sponsor
AstraZeneca
First posted
Apr 27, 2006
Start date
Dec 2003
Completion
Aug 2006
Last update
Jan 21, 2011

Study contacts

AstraZeneca Netherlands Medical Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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