Observation Study of the Clinical Management of Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Chinese Observation Study of the Clinical Management of Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770704
• Other study ID #: NIS-NCN-XXX-2012/1
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: April 6, 2016
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: China Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Hangzhou	Zhejiang
China	Research SIte	Kunming	Yunnan
China	Reserach Site	Shanghai	Shanghai
China	Research Site	Shenzhen	Guangdong
China	Research Site	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes (depression, mania, hypomania or mixed).		Up to 21 months	No
Secondary	Treatments received for Bipolar Disorder: medication time.		Up to 21 months	No
Secondary	Treatments received for Bipolar Disorder: medication classes.		Up to 21 months	No

External Links

•   NIS-NCN-XXX-2012_1-Bipolar Disorder in China_NISR_20151126 CSR Synopsis