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NCT01212575 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01212575
Other study ID # NIS-NDK-SER-2010/2
Secondary ID
Status Completed
Phase N/A
First received September 27, 2010
Last updated March 4, 2011
Start date October 2010
Est. completion date February 2011

Study information
Verified date March 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 186
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Research Site Aabenraa
Denmark Research Site Arhus
Denmark Research Site Arhus N Arhus
Denmark Research Site Arhus S Arhus
Denmark Research Site Ballerup
Denmark Research Site Cph N Cph
Denmark Research Site Cph NV Cph
Denmark Research Site Esbjerg
Denmark Research Site Haderslev
Denmark Research Site Hillerod
Denmark Research Site Middelfart
Denmark Research Site Ronde
Denmark Research Site Tonder

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia Month 1 No
Primary How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia Month 2 No
Primary How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia Month 3 No
Secondary Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR Month 1 No
Secondary Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR Month 2 No
Secondary Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR Month 3 No
Secondary Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics Month 1 No
Secondary Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics Month 2 No
Secondary Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics Month 3 No
Secondary 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 Month 1 No
Secondary 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 Month 2 No
Secondary 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 Month 3 No
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