Official Title: “A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients”

The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• Drug: Quetiapine Fumarate (Seroquel)

Primary Measures

• Change from baseline in PANSS total score at Day 56 (LOCF)

Secondary Measures

• Change from baseline in PANSS positive scale score at Day 56 (LOCF)
• Change from baseline in PANSS negative scale score at Day 56 (LOCF)
• Change from baseline in PANSS EC score at day 56 ,
• Change from baseline in MADRS total score at Day 56. etc

Inclusion Criteria:

• Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian
• Female and/or male, aged between 18 and 60 years (inclusive)
• Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: [20.1] paranoid schizophrenia, [20.2] hebephrenic schizophrenia, [20.3] catatonic schizophrenia, [20.5] undifferentiated schizophrenia

Exclusion Criteria:

• CCMD-3 diagnosis of mental retardation
• Psychosis judged to be the direct physiological effect of an abused medication or substance

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Jon Zhu, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00428350

Study ID Number: D1443L00004

ClinicalTrials.gov Identifier: NCT00428350

Health Authority: China: State Food and Drug Administration