Skip to main content
OpenTrials
Completed

NCT Number: NCT00318539

Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine

Drug

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Apr 27, 2006
Registry last updated
Jan 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.