Quetiapine Augmentation in Severe Obsessive Compulsive Disorder

December 14, 2007 updated by: AstraZeneca

Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany
        • Research Site
      • Lübeck, Germany
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Germany Medical Director, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

November 15, 2005

First Submitted That Met QC Criteria

November 15, 2005

First Posted (Estimate)

November 17, 2005

Study Record Updates

Last Update Posted (Estimate)

December 18, 2007

Last Update Submitted That Met QC Criteria

December 14, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5077/9059
  • D1441C09059

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.

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