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 (SPIN)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01214135
First received: September 24, 2010
Last updated: January 10, 2011
Last verified: January 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 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.


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 Inpatients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia [ Time Frame: every day for the time period of 15 Oct to 31 Dec 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate comorbidities of patients with schizophrenia receiving Seroquel XR and IR [ Time Frame: every day for the time period of 15 Oct to 31 Dec 2010 ] [ Designated as safety issue: No ]
  • To investigate whether Seroquel XR and Seroquel IR are used to treat different types of inpatients with schizophrenia by evaluation of patient characteristics [ Time Frame: every day for the time period of 15 Oct to 31 Dec 2010 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: every day for the time period of 15 Oct to 31 Dec 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with a diagnosis of schizophrenia who have been hospitalized and received at least one dose of Seroquel XR or Seroquel IR during the study period (1st of July 2009 - 30th of September 2010).

  Eligibility

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

Approximately 300 patients with schizophrenia who have been hospitalized during the study period (1st of July 2009 - 30th of September 2010).

Criteria

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").
  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: NCT01214135

Locations
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
Stockholm, Sweden
Research Site
Trollhättan, Sweden
Research Site
Umeå, Sweden
Research Site
Uppsala, Sweden
Research Site
Växjö, Sweden
Research Site
Öjebyn, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dr Eva Dencker Vansvik, MD AstraZeneca
Principal Investigator: Dr Lars Eriksson, MD Rättspsykiatriska Vårdkedjan, Hisings-Backa, Sweden
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01214135     History of Changes
Other Study ID Numbers: NIS-NSE-SER-2010/1
Study First Received: September 24, 2010
Last Updated: January 10, 2011
Health Authority: Sweden: Regional Ethical Review Board

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 August 28, 2014