Observation Study of the Clinical Management of Bipolar Disorder
Completed
- Conditions
- Bipolar Disorder
- Registration Number
- NCT01770704
- Lead Sponsor
- AstraZeneca
- Brief Summary
The objective of the ambispective cohort study is to describe clinical management and clinical outcomes related to bipolar disorder in China, and establish the factors associated with different management patterns and clinical outcomes, provide psychiatrists with reliable and up-to-date information on the disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 520
Inclusion Criteria
- Provision of subject informed consent.
- 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 3 and 12 months prior to the beginning of the study.
Exclusion Criteria
- Inability to complete Patient Reported Outcomes (PROs) questionnaires.
- Participation in an interventional clinical study in last 12 months.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of episodes (depression, mania, hypomania or mixed). Up to 21 months
- Secondary Outcome Measures
Name Time Method Treatments received for Bipolar Disorder: medication classes. Up to 21 months Treatments received for Bipolar Disorder: medication time. Up to 21 months
Trial Locations
- Locations (3)
Research Site
🇨🇳Hangzhou, Zhejiang, China
Reserach Site
🇨🇳Shanghai, Shanghai, China
Research SIte
🇨🇳Kunming, Yunnan, China