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

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:

MedlinePlus related topics: Mental Disorders Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

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

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):

Emborg C, Hallerbäck T, Jörgensen L, Carlborg A. A retrospective study of clinical usage of quetiapine XR and quetiapine IR in outpatients with schizophrenia in Denmark. Hum Psychopharmacol. 2012 Sep;27(5):492-8. doi: 10.1002/hup.2254.

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
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 16, 2013