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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00234377
First received: October 5, 2005
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Seroquel SR
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 550
Study Start Date: November 2004
Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234377

Locations
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
Canada
Research Site
Quebec, Canada
Finland
Research Site
Helsinki, Finland
Research Site
Mikkeli, Finland
Research Site
Turku, Finland
Germany
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
Hungary
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Gyula, Hungary
Research Site
Szekesfehervar, Hungary
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca CNS Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00234377     History of Changes
Other Study ID Numbers: D1444C00147
Study First Received: October 5, 2005
Last Updated: January 3, 2013
Health Authority: Finland: Finnish Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Malaysia: Ministry of Health
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Quetiapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 19, 2014