Study of the Clinical Management of Bipolar Disease
Completed
- Conditions
- Bipolar Disorders
- Registration Number
- NCT01062607
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study is to provide reliable information on the management of bipolar disorders in real every day, clinical practice, to determine the clinical outcomes of such management and use of resources in relation to the disease, and to establish the factors associated with different management patterns and clinical outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2965
Inclusion Criteria
- Diagnosis of Bipolar Disorder I or II (DSM-IV TR) in any phase of the disorder
- Patients who had at least one mood event (depression, mania, hypomania or mixed) according to DSM-IV TR definition during the 12 months prior to the beginning of the study
Exclusion Criteria
- Patients who had the index mood event during the 3 months before the beginning of the study (Time 0).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Demographic variables Once during study 1-year prevalence for each disease phase everytime the patient attends the consult
- Secondary Outcome Measures
Name Time Method Use of resources everytime the patient attends the consult treatments prescribed, EQ5D everytime the patient attends the consult treatments prescribed, FAST everytime the patient attends the consult treatments prescribed, DAI-10 everytime the patient attends the consult treatments prescribed, MPR everytime the patient attends the consult treatments prescribed, BAS Once during the prospective part (only if patient attends with a caregiver)
Trial Locations
- Locations (1)
Research Site
🇻🇪San Cristobal, Venezuela