Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients 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 CNS Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

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 design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The proportion of patients who have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability

Secondary outcome:

The change from baseline in Clinical Global Impression (CGI)-CB score

Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

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

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.

Research Site, Quebec, Canada

Research Site, Helsinki, Finland

Research Site, Mikkeli, Finland

Research Site, Turku, Finland

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

Research Site, Munchen, Bayern, Germany

Research Site, Vancouver, British Columbia, Canada

Research Site, Gottingen, Niedersachsen, Germany

Research Site, 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, Sherbrooke, Quebec, Canada

Research Site, Saint-Laurent, Quebec, Canada

Research Site, Saarbrucken, Saarland, Germany

Research Site, Prince Albert, Saskatchewan, Canada

Starting date: November 2004
Last updated: November 1, 2006