Seroquel Long-Term NIS for Schizophrenia Patients

NCT ID: NCT00523783

Last Updated: 2008-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-05-31

Brief Summary

To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or schizoaffective disorder

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent
• The patient suffers from schizophrenia or schizoaffective disorder according to DSM-IV-TR
• The patient is between 18 and 65 years old(extremes included)
• On the basis of physical and neurological examination, medical history, the patient is, in the investigator's opinion, otherwise healthy
• If the subject is a female of childbearing potential, she must be not pregnant or breast-feeding and be using a reliable method of contraception. Reliable methods may include abstinence, hormonal contraceptives (eg,oral contraceptives or long-term injectable or implantable hormonal contraceptives), double-barrier methods (eg, condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation

Exclusion Criteria

• The patients who have known hypersensitivity to quetiapine

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

Joon-Woo Bahn

Role: STUDY_DIRECTOR

AstraZeneca Korea

Locations

Research Site

Seoul, Dongdamoon-gu, South Korea

Research Site

Seoul, Kangnam-gu, South Korea

Research Site

Seoul, Songpa-gu, South Korea

Countries

South Korea

Other Identifiers

NIS-NKR-SER-2007/1

Identifier Type: -

Identifier Source: org_study_id