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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)

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ClinicalTrials.gov Identifier: NCT01214135
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : January 11, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief 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.

Condition or disease
Schizophrenia

Study Type : Observational
Estimated Enrollment : 300 participants
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
Study Start Date : October 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Group/Cohort
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).



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01214135     History of Changes
Other Study ID Numbers: NIS-NSE-SER-2010/1
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 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