Seroquel Long-Term NIS for Schizophrenia Patients

Schizophrenia Clinical Trial

— SELECT  

Official title:

24-Week Naturalistic Observational Study of Efficacy of Quetiapine in Patients With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523783
• Other study ID #: NIS-NKR-SER-2007/1
• Status: Completed
• Phase: N/A
• First received: August 29, 2007
• Last updated: October 3, 2008
• Start date: May 2007
• Est. completion date: May 2008

Study information

• Verified date: August 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Seoul	Dongdamoon-gu
Korea, Republic of	Research Site	Seoul	Kangnam-gu
Korea, Republic of	Research Site	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

External Links

•   Link