NCT01214135

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

14 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 24, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

Enrollment Period

2 months

First QC Date

September 24, 2010

Last Update Submit

January 10, 2011

Conditions

Schizophrenia

Keywords

Mental disorderantipsychotic treatment

Outcome Measures

Primary Outcomes (1)

  • To investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia

    every day for the time period of 15 Oct to 31 Dec 2010

Secondary Outcomes (3)

  • To investigate comorbidities of patients with schizophrenia receiving Seroquel XR and IR

    every day for the time period of 15 Oct to 31 Dec 2010

  • To investigate whether Seroquel XR and Seroquel IR are used to treat different types of inpatients with schizophrenia by evaluation of patient characteristics

    every day for the time period of 15 Oct to 31 Dec 2010

  • 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

    every day for the time period of 15 Oct to 31 Dec 2010

Study Arms (1)

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 Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • Participation in a clinical trial during the study period.
  • Treatment in forensic care according to LRV ("Lagen om Rättspsykiatrisk Vård").

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Falköping, Sweden

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Helsingborg, Sweden

Location

Research Site

Karlskrona, Sweden

Location

Research Site

Karlstad, Sweden

Location

Research Site

Lund, Sweden

Location

Research Site

Malmo, Sweden

Location

Research Site

Mölndal, Sweden

Location

Research Site

Öjebyn, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Trollhättan, Sweden

Location

Research Site

Umeå, Sweden

Location

Research Site

Uppsala, Sweden

Location

Research Site

Vaxjo, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 23983980DERIVED

MeSH Terms

Conditions

SchizophreniaMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Dr Eva Dencker Vansvik, MD

    AstraZeneca

    STUDY DIRECTOR

  • Dr Lars Eriksson, MD

    Rättspsykiatriska Vårdkedjan, Hisings-Backa, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 24, 2010

First Posted

October 4, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

SE(14)