A Comprehensive Assessment and Follow up Descriptive Study on Bipolar Disorder (CAFE-BD)

December 12, 2013 updated by: Xin Yu, Peking University
The purpose of this study was to investigate the reliability and validity of the bipolar index (BPX) to diagnosis bipolar disorder, and to verify the stability of it in identifying bipolar disorder; the secondary purpose was to understand the dynamic changes of bipolar disorder in natural status.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

970

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Institute of Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The cases were selected from the Sixth Hospital of Peking University and other eight hospitals, and they must meet the diagnosis inclusion criteria of un-bipolar and bipolar disorders. The control group of non-mood disorders will be selected from heathy population who met the following inclusion criteria of healthy controls. Informed consent must be obtained.

Description

Inclusion Criteria:

  1. Age 18-65 years old；
  2. Be able to understand the content of assessment and cooperate；
  3. Currently patients are depressive episode, and / or manic / hypomanic episode, also can be mood stable；
  4. Currently according to diagnostic criteria of the U.S Diagnostic and Statistical Manual Fourth Edition of Mental Disease (DSM-IV) of bipolar disorder (Type I, II, rapid cycling, mixed episodes)；
  5. Currently according to diagnostic criteria of the U.S Diagnostic and Statistical Manual Fourth Edition of Mental Disease (DSM-IV) of depressive disorder；
  6. No other mental illness or a history of physical disease，or patients with physical disease;
  7. Not received modified ECT at least four weeks or more before entering the group.

Exclusion Criteria:

  1. Can not understand the content of assessment and cooperate；
  2. Meet the diagnosis criteria of schizophrenia and other psychotic disorders;
  3. Meet the diagnosis criteria of Diagnosis of mental retardation or pervasive developmental disorder;
  4. Clinically significant neurological disease or loss of consciousness more than one hour of traumatic brain injury；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Bipolar Disorder
Unipolar Disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Test-retest reliability of the scale
Time Frame: one year later
one year later

Secondary Outcome Measures

Outcome Measure
Time Frame
Cronbach's α coefficient of the scale
Time Frame: one year later
one year later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

Shanghai Mental Health Center
West China Hospital
Central South University
Capital Medical University
The First Hospital of Hebei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimate)

December 19, 2013

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011(37)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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