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Status unknownNCT02015143CAFE-BDUpdated Dec 19, 2013

A Comprehensive Assessment and Follow up Descriptive Study on Bipolar Disorder

An observational study in Bipolar Disorder and Unipolar Disorder, sponsored by Peking University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-19.

Sponsored by Peking University · Observational

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Time perspective
Retrospective
Enrollment
970
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bipolar Disorder
  • Unipolar Disorder

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03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's planned enrollment of 970 is above the median of 160 across 329 observational studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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；
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Study design

Time perspective
Retrospective
Enrollment
970 participants (estimated)
Patient registry
No

Groups and cohorts

  • Bipolar Disorder
  • Unipolar Disorder
06

What researchers measure

Primary outcomes

  1. Test-retest reliability of the scale

    Time frame: one year later

Secondary outcomes

  1. Cronbach's α coefficient of the scale

    Time frame: one year later

07

Study locations

1 site
  • Peking University Institute of Mental Health
    Beijing, Beijing 100191, China
08

References and documents

Publications

  • Ma Y, Gao H, Yu X, Si T, Wang G, Fang Y, Liu Z, Sun J, Yang H, Wang X, Li J, Zhang Y, Sachs G. Bipolar diagnosis in China: Evaluating diagnostic confidence using the Bipolarity Index. J Affect Disord. 2016 Sep 15;202:247-53. doi: 10.1016/j.jad.2016.05.039. Epub 2016 May 24. PubMed 27286368 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02015143
Lead sponsor
Peking University
Collaborators
Capital Medical University, Shanghai Mental Health Center, The First Hospital of Hebei Medical University, Central South University, West China Hospital
Responsible party
Xin Yu (President, Peking University) — Principal investigator
First posted
Dec 19, 2013
Start date
Jan 2012
Primary completion
Mar 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Dec 19, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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