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Seroquel Long-Term NIS for Schizophrenia Patients (SELECT)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00523783
First received: August 29, 2007
Last updated: October 3, 2008
Last verified: August 2007
History of Changes
  Purpose

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


Condition
Schizophrenia
Schizoaffective Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 24-Week Naturalistic Observational Study of Efficacy of Quetiapine in Patients With Schizophrenia or Schizoaffective Disorder

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Estimated Enrollment: 1000
Study Start Date: May 2007
Study Completion Date: May 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523783

Locations
Korea, Republic of
Research Site
Seoul, Dongdamoon-gu, Korea, Republic of
Research Site
Seoul, Kangnam-gu, Korea, Republic of
Research Site
Seoul, Songpa-gu, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joon-Woo Bahn AstraZeneca Korea
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00523783     History of Changes
Other Study ID Numbers: NIS-NKR-SER-2007/1
Study First Received: August 29, 2007
Last Updated: October 3, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Schizophrenia
Schizoaffective
quetiapine
 long-term efficacy
Naturalistic
Observational

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013