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Seroquel Long-Term NIS for Schizophrenia Patients (SELECT)

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ClinicalTrials.gov Identifier: NCT00523783
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : October 6, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or schizoaffective disorder

Condition or disease
Schizophrenia Schizoaffective Disorder

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Time Perspective: Prospective
Official Title: 24-Week Naturalistic Observational Study of Efficacy of Quetiapine in Patients With Schizophrenia or Schizoaffective Disorder
Study Start Date : May 2007
Primary Completion Date : November 2007
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00523783     History of Changes
Other Study ID Numbers: NIS-NKR-SER-2007/1
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: October 6, 2008
Last Verified: August 2007

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

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs