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

Bipolar Disorder Clinical Trial

— REED  

Official title:

An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder Treated With Quetiapine XR and/or Quetiapine IR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455961
• Other study ID #: VD-NS-1101
• Status: Completed
• Phase: N/A
• First received: October 17, 2011
• Last updated: August 20, 2014
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: National Board of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16000
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No

External Links

•   Link
•   Redacted_protocol