Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

NCT00318539 | Completed Phase 2

• 1 other identifier: D1441C09907
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (2)

• 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".

Secondary Outcomes (2)

• The onset of response to treatment, using the time to a sustained response as criterion

• Side effect profiles, Quality of life, Cognitive functioning

Interventions

Quetiapine DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• AstraZeneca Netherlands Medical Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 27, 2006
• Study Start: December 1, 2003
• Study Completion: August 1, 2006
• Last Updated: January 21, 2011

Record last verified: 2011-01

Locations

NL (1)