Trial record 9 of 208 for:
Open Studies | "Bipolar Disorder"
Observation Study of the Clinical Management of Bipolar Disorder
This study is currently recruiting participants.
Verified March 2013 by AstraZeneca
Information provided by (Responsible Party):
First received: January 16, 2013
Last updated: March 4, 2013
Last verified: March 2013
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.
||Observational Model: Cohort
||Chinese Observation Study of the Clinical Management of Bipolar Disorder
Primary Outcome Measures:
- Number of episodes (depression, mania, hypomania or mixed). [ Time Frame: Up to 21 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Treatments received for Bipolar Disorder: medication time. [ Time Frame: Up to 21 months ] [ Designated as safety issue: No ]
- Treatments received for Bipolar Disorder: medication classes. [ Time Frame: Up to 21 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
Patients diagnosed with bipolar disorder I or II
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients diagnosed with bipolar disorder I or II with at least one mood event during the 3 and 12 months prior to the beginning of the study.
- 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.
- Inability to complete Patient Reported Outcomes (PROs) questionnaires.
- Participation in an interventional clinical study in last 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770704
|Beijing, Beijing, China |
|Shenzhen, Guangdong, China |
|Shanghai, Shanghai, China |
|Xi'an, Shanxi, China |
|Kunming, Yunnan, China |
|Hangzhou, Zhejiang, China |
||Beijing No.6 Hospital
||Capital Medical University
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 16, 2013
||March 4, 2013
||China: Ethics Committee
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Affective Disorders, Psychotic