Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia

January 3, 2013 updated by: AstraZeneca

6-week Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-release Quetiapine Fumarate (SEROQUEL) to Sustained-release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbreviated)

The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation.

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 (Actual)

454

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

  • Australia
      • QLD, Australia
        • Research Site
  • Bulgaria
      • Burgas, Bulgaria
        • Research Site
      • Radnevo, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • 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
      • Sherbrooke, Quebec, Canada
        • Research Site
    • Saskatchewan
      • Prince Albert, Saskatchewan, Canada
        • Research Site
  • Estonia
      • Põltsamaa, Estonia
        • Research Site
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Mikkeli, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • Germany
      • Halle, Germany
        • Research Site
      • Marburg, Germany
        • Research Site
    • Bayern
      • München, Bayern, Germany
        • Research Site
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany
        • Research Site
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany
        • Research Site
      • Aachen, Nordrhein-Westfalen, Germany
        • Research Center
    • Thüringen
      • Jena, Thüringen, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Nagykálló, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Székesfehérvár, Hungary
        • Research Site
  • Italy
      • Quartu Sant Elena, Italy, CA
        • Research Site
    • BO
      • Bologna, BO, Italy
        • Research Site
    • CA
      • Cagliari, CA, Italy
        • Research Site
    • PG
      • Citta' di Castello, PG, Italy
        • Research Site
      • Ellera di Corciano, PG, Italy
        • Research Site
    • TO
      • Torino, TO, Italy
        • Research Site
    • VI
      • Bassano Del Grappa, VI, Italy
        • Research Site
  • Latvia
      • Riga, Latvia
        • Research Site
      • Sigulda, Latvia
        • Research Site
  • Lithuania
      • Klapeda, Lithuania
        • Research Site
      • Siauliai, Lithuania
        • Research Site
      • Vilnius, Lithuania
        • Research Sitte
    • Kaunas
      • Ziegzdrai, Kaunas, Lithuania
        • Research Site
  • Spain
      • Madrid, Spain
        • Research Site
      • Villamartin, Spain
        • Research Site
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain
        • Research Site
    • Madrid
      • Alcobendas, Madrid, Spain
        • Research Site
      • Colmenar Viejo, Madrid, Spain
        • Research Site
      • Mostoles, Madrid, Spain
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Cerritos, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • National City, California, United States
        • Research Site
      • Pasadena, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Santa Ana, California, United States
        • Research Site
    • Florida
      • North Miami, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Illinois
      • Hoffman Estates, Illinois, United States
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Research Site
    • New Jersey
      • Clementon, New Jersey, United States
        • Research Site
    • New York
      • Staten Island, New York, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • 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:

  • A stable dose of quetiapine IR between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (Visit 1) as judged by the investigator.
  • 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.
  • Patients with 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more
Time Frame: from randomisation to any visit
from randomisation to any visit

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in PANSS total score
Time Frame: from randomization to week 6
from randomization to week 6
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
Time Frame: from randomization to week 6
from randomization to week 6
The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4
Time Frame: at week 6
at week 6

Collaborators and Investigators

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

Sponsor

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

November 1, 2004

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 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

  • D1444C00146

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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