A Comprehensive Assessment and Follow up Descriptive Study on Bipolar Disorder

Bipolar Disorder Clinical Trial

— CAFE-BD  

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02015143
• Other study ID #: 2011(37)
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 3, 2013
• Last updated: December 12, 2013
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 970
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Unipolar Disorder

Locations

Country	Name	City	State
China	Peking University Institute of Mental Health	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Peking University	Capital Medical University, Central South University, Hebei Medical University First Hospital, Shanghai Mental Health Center, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test-retest reliability of the scale		one year later	No
Secondary	Cronbach's a coefficient of the scale		one year later	No