Observation Study of the Clinical Management of Bipolar Disorder

Brief Summary

Official Title: “Chinese Observation Study of the Clinical Management of Bipolar Disorder”

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.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort
  • Study Primary Completion Date: July 2014

Arms, Groups and Cohorts in this Clinical Trial

  • Patients diagnosed with bipolar disorder I or II

Outcome Measures for this Clinical Trial

Primary Measures

  • Number of episodes (depression, mania, hypomania or mixed).
    • Time Frame: Up to 21 months
      Safety Issue?: No

Secondary Measures

  • Treatments received for Bipolar Disorder: medication time.
    • Time Frame: Up to 21 months
      Safety Issue?: No
  • Treatments received for Bipolar Disorder: medication classes.
    • Time Frame: Up to 21 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yu Xin, Principal Investigator, Beijing No.6 Hospital
    • Wang Gang, Principal Investigator, Capital Medical University

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01770704