- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318539
Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study
Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-blind, Placebo-controlled 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.
Study Overview
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Utrecht, Netherlands
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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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".
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Secondary Outcome Measures
Outcome Measure |
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The onset of response to treatment, using the time to a sustained response as criterion
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Side effect profiles, Quality of life, Cognitive functioning
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Personality Disorders
- Anxiety Disorders
- Disease
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- D1441C09907
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obsessive Compulsive Disorder
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Anne Katrine PagsbergCopenhagen Trial Unit, Center for Clinical Intervention Research; Danish Research...Active, not recruitingObsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceDenmark
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Baylor College of MedicineRecruitingObsessive-Compulsive Disorder | Cognitive Behavioral Therapy | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceUnited States
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Chaim HuijserLevvelRecruitingObsessive-Compulsive Disorder | Anxiety Disorders and Symptoms | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceNetherlands
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Stanford UniversityCompletedObsessive Compulsive DisorderUnited States
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NYU Langone HealthCompletedObsessive Compulsive DisorderUnited States
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Massachusetts General HospitalActive, not recruitingObsessive Compulsive DisorderUnited States
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Boston University Charles River CampusCompletedObsessive Compulsive DisorderUnited States
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Butler HospitalNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive DisorderUnited States
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Karolinska InstitutetCompletedObsessive Compulsive DisorderSweden
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Roseli ShavittCompleted
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