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Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients With Schizophrenia
This study has been completed.
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00234377
  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 III

MedlinePlus related topics: Schizophrenia
Drug Information available for: Quetiapine Quetiapine fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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

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

  Show 27 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca CNS Medical Science Director, MD AstraZeneca
  More Information

Publications indexed to this study:
Study ID Numbers: D1444C00147
Study First Received: October 5, 2005
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00234377  
Health Authority: Finland: National Agency for Medicines;   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

Study placed in the following topic categories:
Schizophrenia
Quetiapine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009