An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder (REED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01455961
First received: October 17, 2011
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition
Bipolar Disorder

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder Treated With Quetiapine XR and/or Quetiapine IR

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: 1st of January 2009 to 31st of December 2010. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1st of January 2009 to 31st of December 2010. ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1st of January 2009 to 31st of December 2010. ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1st of January 2009 to 31st of December 2010. ] [ Designated as safety issue: No ]

Enrollment: 16000
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Detailed Description:

An epidemiological registry study to evaluate clinical practice treatment in patients with Bipolar Disorder treated with quetiapine XR and/or quetiapine IR

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  • Patients with a diagnosis of BD.

Exclusion Criteria:

  • Patients with a diagnosis of any schizophrenia spectrum disorder after the diagnosis of bipolar disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455961

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Andreas Carlborg, MD Department of Clinical Neuroscience, Karolinska Institutet 171 76 Stockholm
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01455961     History of Changes
Other Study ID Numbers: VD-NS-1101
Study First Received: October 17, 2011
Last Updated: January 28, 2013
Health Authority: Sweden: National Board of Health and Welfare

Keywords provided by AstraZeneca:
Real life setting
Bipolar Disorder
Registry based Data Base Audit

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014