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

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)”

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.

Intervention(s) in this Clinical Trial

• Drug: Seroquel SR

Primary Measures

• 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
  • Time Frame: from randomisation to any visit
    Safety Issue?: No

Secondary Measures

• The change in PANSS total score
  • Time Frame: from randomization to week 6
    Safety Issue?: No
• The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
  • Time Frame: from randomization to week 6
    Safety Issue?: No
• The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4
  • Time Frame: at week 6
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

AstraZeneca Seroquel Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00206128

Study ID Number: D1444C00146

ClinicalTrials.gov Identifier: NCT00206128

Health Authority: United States: Food and Drug Administration