Seroquel Long-Term NIS for Schizophrenia Patients (SELECT)

October 3, 2008 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Dongdamoon-gu
      • Seoul, Dongdamoon-gu, Korea, Republic of
        • Research Site
    • Kangnam-gu
      • Seoul, Kangnam-gu, Korea, Republic of
        • Research Site
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Joon-Woo Bahn, AstraZeneca Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

August 31, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2008

Last Update Submitted That Met QC Criteria

October 3, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NKR-SER-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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