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Quetiapine Augmentation in Severe Obsessive Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00254735
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : December 18, 2007
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of the study is to evaluate the efficacy of quetiapine or placebo added to baseline treatment of SSRI/clomipramine for the treatment of OCD in adult subjects.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: quetiapine fumarate Drug: SSRI/Clomipramine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study
Study Start Date : April 2002
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.

Secondary Outcome Measures :
  1. Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales.
  2. Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent, men and women aged ³18 to £65 years with diagnosis of OCD, at least 12 weeks of treatment with SSRI or clomipramine

Exclusion Criteria:

  • Substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intolerance or lack of response to quetiapine, use of antihypertensive medication with changing doses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254735


Locations
Germany
Research Site
Freiburg, Germany
Research Site
Lübeck, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Germany Medical Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00254735     History of Changes
Other Study ID Numbers: 5077/9059
D1441C09059
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: December 18, 2007
Last Verified: December 2007

Keywords provided by AstraZeneca:
Obsessive Compulsive Disorder (OCD)

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Quetiapine Fumarate
Clomipramine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents