NCT01212575

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 outpatients 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

4 months

First QC Date

September 27, 2010

Last Update Submit

March 4, 2011

Conditions

Schizophrenia

Keywords

Mental disorderAntipsychotic treatment

Outcome Measures

Primary Outcomes (3)

  • How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia

    Month 1

  • How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia

    Month 2

  • How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia

    Month 3

Secondary Outcomes (9)

  • Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR

    Month 1

  • Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR

    Month 2

  • Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR

    Month 3

  • Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics

    Month 1

  • Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics

    Month 2

  • +4 more secondary outcomes

Study Arms (1)

300 patients

Female or male aged 18-65 years with a diagnosis of schizophrenia having received at least one dose of Seroquel XR or Seroquel IR during January - March 2010

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a diagnosis of schizophrenia who are registered at an outpatient district psychiatric clinic

You may qualify if:

  • Adults with a diagnosis of schizophrenia from a district psychiatric clinic in Denmark
  • Patients who have received at least one dose of Seroquel XR or Seroquel IR during January - March 2010

You may not qualify if:

  • Patients already participating in a clinical study during the study-period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Aabenraa, Aabenraa, Denmark

Location

Research Site

Aarhus, Arhus, Denmark

Location

Research Site

Arhus N, Arhus, Denmark

Location

Research Site

Arhus S, Arhus, Denmark

Location

Research Site

Ballerup Municipality, Ballerup, Denmark

Location

Research Site

Cph NV, Cph, Denmark

Location

Research Site

Cph N, Cph, Denmark

Location

Research Site

Esbjerg, Esbjerg, Denmark

Location

Research Site

Haderslev, Haderslev, Denmark

Location

Research Site

Hillerød, Hillerod, Denmark

Location

Research Site

Middelfart, Middelfart, Denmark

Location

Research Site

Rønde, Ronde, Denmark

Location

Research Site

Tønder, Tonder, Denmark

Location

Related Publications (1)

  • Emborg C, Hallerback T, Jorgensen L, Carlborg A. A retrospective study of clinical usage of quetiapine XR and quetiapine IR in outpatients with schizophrenia in Denmark. Hum Psychopharmacol. 2012 Sep;27(5):492-8. doi: 10.1002/hup.2254.

    PMID: 22996616DERIVED

MeSH Terms

Conditions

SchizophreniaMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Eva Dencker Vansvik

    AstraZeneca Nordic-Södertälje, Sweden

    STUDY DIRECTOR

  • Charlotte Emborg

    Skovager 2, Risskov, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 30, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations

DK(13)