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Completed

NCT Number: NCT01770704

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of episodes (depression, mania, hypomania or mixed).

    Time frame: Up to 21 months

Secondary outcomes

  1. Treatments received for Bipolar Disorder: medication time.

    Time frame: Up to 21 months

  2. Treatments received for Bipolar Disorder: medication classes.

    Time frame: Up to 21 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Chinese Observation Study of the Clinical Management of Bipolar Disorder

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 18, 2013
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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