A Retrospective Non-interventional Study to Evaluate the Use of Seroquel Extended Release (XR) and Immediate Release (IR) in the Clinical Practice of Inpatients With Schizophrenia

Schizophrenia Clinical Trial

— SPIN  

Official title:

A Retrospective, Non-interventional Study to Evaluate the Use of Seroquel XR and Seroquel IR in the Clinical Practice of Inpatients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214135
• Other study ID #: NIS-NSE-SER-2010/1
• Status: Completed
• Phase: N/A
• First received: September 24, 2010
• Last updated: January 10, 2011
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• 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 inpatients 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: 300
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia.

• At least one dose of Seroquel XR or Seroquel IR during the study period (1st of July 2009 - 30th of September 2010).

• Hospitalization due to psychotic symptoms at any time during the study period (1st of July 2009 - 30th of September 2010) and with admission and discharge dates available.

Exclusion Criteria:

• Participation in a clinical trial during the study period.

• Treatment in forensic care according to LRV ("Lagen om Rättspsykiatrisk Vård").

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Sweden	Research Site	Falköping
Sweden	Research Site	Gothenburg
Sweden	Research Site	Helsingborg
Sweden	Research Site	Karlskrona
Sweden	Research Site	Karlstad
Sweden	Research Site	Lund
Sweden	Research Site	Malmö
Sweden	Research Site	Mölndal
Sweden	Research Site	Öjebyn
Sweden	Research Site	Stockholm
Sweden	Research Site	Trollhättan
Sweden	Research Site	Umeå
Sweden	Research Site	Uppsala
Sweden	Research Site	Växjö

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia		every day for the time period of 15 Oct to 31 Dec 2010	No
Secondary	To investigate comorbidities of patients with schizophrenia receiving Seroquel XR and IR		every day for the time period of 15 Oct to 31 Dec 2010	No
Secondary	To investigate whether Seroquel XR and Seroquel IR are used to treat different types of inpatients with schizophrenia by evaluation of patient characteristics		every day for the time period of 15 Oct to 31 Dec 2010	No
Secondary	To investigate 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		every day for the time period of 15 Oct to 31 Dec 2010	No