A Retrospective NIS to Evaluate the Use of Seroquel XR and IR in the Clinical Practice of Outpatients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01212575
First received: September 27, 2010
Last updated: March 4, 2011
Last verified: March 2011
  Purpose

The primary objective of this non-interventional study is to investigate how Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia. This will be done by a retrospective review of medical records to evaluate patients treated with Seroquel XR or Seroquel IR as primary antipsychotic treatment.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Retrospective, Non-interventional Study to Evaluate the Use of Seroquel XR and Seroquel IR in the Clinical Practice of Outpatients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
  • How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
  • Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
  • Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • The treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • The treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
  • The treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: October 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
300 patients
Female or male aged 18-65 years with a diagnosis of schizophrenia having received at least one dose of Seroquel XR or Seroquel IR during January - March 2010

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with a diagnosis of schizophrenia who are registered at an outpatient district psychiatric clinic

Criteria

Inclusion Criteria:

  • Adults with a diagnosis of schizophrenia from a district psychiatric clinic in Denmark
  • Patients who have received at least one dose of Seroquel XR or Seroquel IR during January - March 2010

Exclusion Criteria:

  • Patients already participating in a clinical study during the study-period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212575

Locations
Denmark
Research Site
Arhus N, Arhus, Denmark
Research Site
Arhus S, Arhus, Denmark
Research Site
Cph N, Cph, Denmark
Research Site
Cph NV, Cph, Denmark
Research Site
Aabenraa, Denmark
Research Site
Arhus, Denmark
Research Site
Ballerup, Denmark
Research Site
Esbjerg, Denmark
Research Site
Haderslev, Denmark
Research Site
Hillerod, Denmark
Research Site
Middelfart, Denmark
Research Site
Ronde, Denmark
Research Site
Tonder, Denmark
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Dencker Vansvik AstraZeneca Nordic-Södertälje, Sweden
Principal Investigator: Charlotte Emborg Skovager 2, Risskov, Denmark
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Dencker Vansvik, Marketing Company Medical Director (MC MD), AstraZeneca
ClinicalTrials.gov Identifier: NCT01212575     History of Changes
Other Study ID Numbers: NIS-NDK-SER-2010/2
Study First Received: September 27, 2010
Last Updated: March 4, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by AstraZeneca:
Mental disorder
Antipsychotic treatment

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 22, 2014