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

Condition(s) targeted: Schizophrenia

Intervention: Seroquel SR (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: 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)

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome:

The change in PANSS total score

The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively

The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Research Site, QLD, Australia

Research Site, Burgas, Bulgaria

Research Site, Radnevo, Bulgaria

Research Site, Varna, Bulgaria

Research Site, Quebec, Canada

Research Site, Põltsamaa, Estonia

Research Site, Tallinn, Estonia

Research Site, Tartu, Estonia

Research Site, Helsinki, Finland

Research Site, Mikkeli, Finland

Research Site, Turku, Finland

Research Site, Halle, Germany

Research Site, Marburg, Germany

Research Site, Budapest, Hungary

Research Site, Debrecen, Hungary

Research Site, Gyula, Hungary

Research Site, Nagykálló, Hungary

Research Site, Szeged, Hungary

Research Site, Székesfehérvár, Hungary

Research Site, Quartu Sant Elena CA, Italy

Research Site, Riga, Latvia

Research Site, Sigulda, Latvia

Research Site, Klapeda, Lithuania

Research Site, Siauliai, Lithuania

Research Sitte, Vilnius, Lithuania

Research Site, Villamartin, Spain

Research Site, Madrid, Spain

Research Site, Birmingham, Alabama, United States

Research Site, Bologna, BO, Italy

Research Site, München, Bayern, Germany

Research Site, Vancouver, British Columbia, Canada

Research Site, CAGLIARI, CA, Italy

Research Site, 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, Jerez de la Frontera, Cádiz, Spain

Research Site, North Miami, Florida, United States

Research Site, Atlanta, Georgia, United States

Research Site, Hoffman Estates, Illinois, United States

Research Site, Ziegzdrai, Kaunas, Lithuania

Research Site, New Orleans, Louisiana, United States

Research Site, Alcobendas, Madrid, Spain

Research Site, Colmenar Viejo, Madrid, Spain

Research Site, Mostoles, Madrid, Spain

Research Site, Jackson, Mississippi, United States

Research Site, Clementon, New Jersey, United States

Research Site, Staten Island, New York, United States

Research Site, Göttingen, Niedersachsen, Germany

Research Site, Aachen, Nordrhein-Westfalen, Germany

Research Center, Aachen, Nordrhein-Westfalen, Germany

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

Research Site, Citta' di Castello, PG, Italy

Research Site, Ellera di Corciano, PG, Italy

Research Site, Sherbrooke, Quebec, Canada

Research Site, Prince Albert, Saskatchewan, Canada

Research Site, Austin, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Jena, Thüringen, Germany

Research Site, Bassano Del Grappa, VI, Italy

Research Site, Richmond, Virginia, United States

Research Site, Torino, to, Italy

Starting date: November 2004
Ending date: March 2006
Last updated: May 2, 2008