An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder (REED)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01455961
First received: October 17, 2011
Last updated: January 28, 2013
Last verified: January 2013
| Tracking Information | |||||
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| First Received Date ICMJE | October 17, 2011 | ||||
| Last Updated Date | January 28, 2013 | ||||
| Start Date ICMJE | November 2011 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01455961 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder | ||||
| Official Title ICMJE | An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder Treated With Quetiapine XR and/or Quetiapine IR | ||||
| 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. |
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| Detailed Description | An epidemiological registry study to evaluate clinical practice treatment in patients with Bipolar Disorder treated with quetiapine XR and/or quetiapine IR |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Bipolar Disorder | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 16000 | ||||
| Completion Date | April 2012 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01455961 | ||||
| Other Study ID Numbers ICMJE | VD-NS-1101 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | AstraZeneca | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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