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

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: NCT00234377
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : January 4, 2013
Information provided by:

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Seroquel SR Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2004
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. The change from baseline in Clinical Global Impression (CGI)-CB score
  2. Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

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

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.

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): NCT00234377

Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Ontario
Research Site
Aurora, Ontario, Canada
Research Site
Burlington, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Orleans, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Saint-Laurent, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Canada, Saskatchewan
Research Site
Prince Albert, Saskatchewan, Canada
Research Site
Quebec, Canada
Research Site
Helsinki, Finland
Research Site
Mikkeli, Finland
Research Site
Turku, Finland
Research Site
Munchen, Bayern, Germany
Research Site
Gottingen, Niedersachsen, Germany
Research Site
Aachen, Nordrhein-Westfalen, Germany
Research Site
Saarbrucken, Saarland, Germany
Research Site
Aachen, Germany
Research Site
Gottingen, Germany
Research Site
Halle, Germany
Research Site
Homburg, Germany
Research Site
Jena, Germany
Research Site
Munchen, Germany
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Gyula, Hungary
Research Site
Szekesfehervar, Hungary
Sponsors and Collaborators
Study Director: AstraZeneca CNS Medical Science Director, MD AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00234377     History of Changes
Other Study ID Numbers: D1444C00147
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Quetiapine Fumarate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs