NCT01455961

Brief Summary

The aim of this study is to describe the treatment pattern and patient characteristics in real life setting in patients with Bipolar disorder treated with Seroquel XR and/or Seroquel IR in Sweden.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

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

October 17, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

October 17, 2011

Last Update Submit

August 20, 2014

Conditions

Keywords

Real life settingBipolar DisorderRegistry based Data Base Audit

Outcome Measures

Primary Outcomes (1)

  • Description of detailed clinical treatment in terms of duration of treatment, doses, drug switches, and add-on therapy, in patients with BD and on treatment with quetiapine XR and/or quetiapine IR before, at and after the index date.

    1st of January 2009 to 31st of December 2010.

Secondary Outcomes (3)

  • Description of co-morbidity, demographics, sick leave, early retirement and socioeconomic factors in patients with BD and on treatment with quetiapine XR and/or quetiapine IR before and at the index date.

    1st of January 2009 to 31st of December 2010.

  • Description of the detailed clinical treatment in terms of duration of treatment, doses, drug switches, and add-on therapy, in patients with BD, including all drug treatment after the index date

    1st of January 2009 to 31st of December 2010.

  • Description of co-morbidity, demographics, sick leave, early retirement and socioeconomic factors in patients with BD, including all drug treatment before and at the index date

    1st of January 2009 to 31st of December 2010.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who have been hospitalised in Sweden at least once since 1987 with a diagnosis during hospitalisation of Bipolar Disorder.

You may qualify if:

  • Patients with a diagnosis of BD.

You may not qualify if:

  • Patients with a diagnosis of any schizophrenia spectrum disorder after the diagnosis of bipolar disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Carlborg A, Thuresson M, Ferntoft L, Bodegard J. Characteristics of bipolar disorder patients treated with immediate- and extended-release quetiapine in a real clinical setting: a longitudinal, cohort study of 1761 patients. Ther Adv Psychopharmacol. 2015 Feb;5(1):13-21. doi: 10.1177/2045125314560740.

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Andreas Carlborg, MD

    Department of Clinical Neuroscience, Karolinska Institutet 171 76 Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 20, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 21, 2014

Record last verified: 2014-08