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

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

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. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Key facts

Study ID

NCT00206128

Run by

AstraZeneca

People needed

454

Starts

2004-11-01

Expected to finish

2006-02-01

Last updated by the study team

2013-01-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 — North Miami, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Hoffman Estates, Illinois, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Jackson, Mississippi, United States
• Research Site — Clementon, New Jersey, United States
• Research Site — Staten Island, New York, United States
• Research Site — Austin, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Richmond, Virginia, United States
• Research Site — QLD, Australia
• Research Site — Burgas, Bulgaria
• Research Site — Radnevo, Bulgaria
• Research Site — Varna, Bulgaria
• Research Site — Vancouver, British Columbia, Canada
• Research Site — Aurora, Ontario, Canada
• Research Site — Burlington, Ontario, Canada
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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