Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients With Schizophrenia

January 3, 2013 updated by: AstraZeneca

A 12-week International, Multicenter, Open Label, Non-comparative Study to Evaluate the Feasibility of Switching Any Antipsychotic Treatment to Sustained-release Quetiapine Fumarate (SEROQUEL®) in Patients With Schizophrenia

The purpose of this study is to document the clinical benefit of quetiapine (Seroquel) sustained release (SR) after switching from another ongoing antipsychotic treatment, regardless of the reason for the switch.

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

550

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

  • Canada
      • Quebec, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Ontario
      • Aurora, Ontario, Canada
        • Research Site
      • Burlington, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • Orleans, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Saint-Laurent, Quebec, Canada
        • Research Site
      • Sherbrooke, Quebec, Canada
        • Research Site
    • Saskatchewan
      • Prince Albert, Saskatchewan, Canada
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Mikkeli, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • Germany
      • Aachen, Germany
        • Research Site
      • Gottingen, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Homburg, Germany
        • Research Site
      • Jena, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
    • Bayern
      • Munchen, Bayern, Germany
        • Research Site
    • Niedersachsen
      • Gottingen, Niedersachsen, Germany
        • Research Site
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany
        • Research Site
    • Saarland
      • Saarbrucken, Saarland, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Szekesfehervar, Hungary
        • 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who in their own and/or in the Investigator's opinion, consider ongoing antipsychotic treatment inadequate, because of insufficient efficacy and/or tolerability.
  • Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
  • Able to understand and comply with the requirements of the study, as judged by the Investigator.

Exclusion Criteria:

  • Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation.
  • Substance abuse or dependence as defined by DSM-IV and not in full remission. A urine drug screen test will be performed. The Investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
  • Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the Investigator.
  • Patients who, in the opinion of the Investigator, pose an imminent risk of suicide or a danger to self or others.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The proportion of patients who have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability

Secondary Outcome Measures

Outcome Measure
The change from baseline in Clinical Global Impression (CGI)-CB score
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca CNS Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2004

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

October 5, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (Estimate)

October 7, 2005

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1444C00147

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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