Observation Study of the Clinical Management of Bipolar Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01770704
First received: January 16, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Chinese Observation Study of the Clinical Management of Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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: 500
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients diagnosed with bipolar disorder I or II

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770704

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Shenzhen, Guangdong, China
China, Shanghai
Reserach Site
Shanghai, Shanghai, China
China, Shanxi
Research Site
Xi'an, Shanxi, China
China, Yunnan
Research SIte
Kunming, Yunnan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Yu Xin Beijing No.6 Hospital
Principal Investigator: Wang Gang Capital Medical University
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01770704     History of Changes
Other Study ID Numbers: NIS-NCN-XXX-2012/1
Study First Received: January 16, 2013
Last Updated: April 1, 2014
Health Authority: China: China Ethics Committee

Keywords provided by AstraZeneca:
Bipolar disorder
Clinical management
Clinical outcomes

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014