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:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01214135
First received: September 24, 2010
Last updated: January 10, 2011
Last verified: January 2011
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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
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 May 21, 2013