Clinical trial NCT01214135: 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Mental disorder
antipsychotic treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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).

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.


Eligibility 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").

Primary outcomes:
measure: To investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia
timeFrame: every day for the time period of 15 Oct to 31 Dec 2010
Secondary outcomes:
measure: To investigate comorbidities of patients with schizophrenia receiving Seroquel XR and IR
timeFrame: every day for the time period of 15 Oct to 31 Dec 2010
measure: To investigate whether Seroquel XR and Seroquel IR are used to treat different types of inpatients with schizophrenia by evaluation of patient characteristics
timeFrame: every day for the time period of 15 Oct to 31 Dec 2010
measure: 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
timeFrame: every day for the time period of 15 Oct to 31 Dec 2010
Other outcomes:
Locations:
city: Falköping
country: Sweden
facility: Research Site
city: Gothenburg
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Karlskrona
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Mölndal
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Växjö
country: Sweden
facility: Research Site
city: Öjebyn
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Dr Eva Dencker Vansvik, MD
role: STUDY_DIRECTOR
affiliation: Rättspsykiatriska Vårdkedjan, Hisings-Backa, Sweden
name: Dr Lars Eriksson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eriksson L, Hallerback T, Jorgensen L, Carlborg A. Use of quetiapine XR and quetiapine IR in clinical practice for hospitalized patients with schizophrenia: a retrospective study. Ther Adv Psychopharmacol. 2012 Dec;2(6):217-26. doi: 10.1177/2045125312453935.