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Observation Study of the Clinical Management of Bipolar Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01770704
First Posted: January 18, 2013
Last Update Posted: April 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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 ]

Secondary Outcome Measures:
  • Treatments received for Bipolar Disorder: medication time. [ Time Frame: Up to 21 months ]
  • Treatments received for Bipolar Disorder: medication classes. [ Time Frame: Up to 21 months ]

Enrollment: 520
Study Start Date: February 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients diagnosed with bipolar disorder I or II

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01770704     History of Changes
Other Study ID Numbers: NIS-NCN-XXX-2012/1
First Submitted: January 16, 2013
First Posted: January 18, 2013
Last Update Posted: April 7, 2016
Last Verified: April 2016

Keywords provided by AstraZeneca:
Bipolar disorder
Clinical management
Clinical outcomes

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders