We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01212575
First Posted: September 30, 2010
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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 ]
  • How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia [ Time Frame: Month 2 ]
  • How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia [ Time Frame: Month 3 ]

Secondary Outcome Measures:
  • Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR [ Time Frame: Month 1 ]
  • Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR [ Time Frame: Month 2 ]
  • Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR [ Time Frame: Month 3 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT01212575


Locations
Denmark
Research Site
Arhus N, Arhus, Denmark
Research Site
Arhus S, Arhus, Denmark
Research Site
Cph NV, Cph, Denmark
Research Site
Cph N, 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

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
First Submitted: September 27, 2010
First Posted: September 30, 2010
Last Update Posted: March 8, 2011
Last Verified: March 2011

Keywords provided by AstraZeneca:
Mental disorder
Antipsychotic treatment

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