Bipolar DisorderCAFE-BDNCT02015143
A Comprehensive Assessment and Follow up Descriptive Study on Bipolar Disorder
An observational study of Bipolar Disorder and Unipolar Disorder, run by Peking University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Unipolar Disorder
- How many people
- 970 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18-65 years old；
- Be able to understand the content of assessment and cooperate；
- Currently patients are depressive episode, and / or manic / hypomanic episode, also can be mood stable；
- 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)；
- Currently according to diagnostic criteria of the U.S Diagnostic and Statistical Manual Fourth Edition of Mental Disease (DSM-IV) of depressive disorder；
- No other mental illness or a history of physical disease，or patients with physical disease;
- Not received modified ECT at least four weeks or more before entering the group.
Who cannot join
- Can not understand the content of assessment and cooperate；
- Meet the diagnosis criteria of schizophrenia and other psychotic disorders;
- Meet the diagnosis criteria of Diagnosis of mental retardation or pervasive developmental disorder;
- Clinically significant neurological disease or loss of consciousness more than one hour of traumatic brain injury；
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Institute of Mental Health
Beijing, Beijing Municipality, 100191
About this study
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.
- Conditions
- Bipolar Disorder, Unipolar Disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder | Not described | |
| Unipolar Disorder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reliability of the scale
Measured: one year later
Secondary outcomes (1)
Cronbach's α coefficient of the scale
Measured: one year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 970 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University, Shanghai Mental Health Center, The First Hospital of Hebei Medical University, Central South University, West China Hospital
- Responsible party
- Principal investigator, Xin Yu, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015143
- Sponsor's protocol ID
- 2011(37)
- Acronym
- CAFE-BD
- Status last verified
- Dec 2013
- First submitted
- 3 Dec 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Assessment and Follow up Descriptive Study on Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02015143
- Acronym / sponsor ID
- CAFE-BD / 2011(37)
- Conditions
- Bipolar Disorder, Unipolar Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 970 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Capital Medical University, Shanghai Mental Health Center, The First Hospital of Hebei Medical University, Central South University, West China Hospital
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder | – | – |
| Unipolar Disorder | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Age 18-65 years old；
- Be able to understand the content of assessment and cooperate；
- Currently patients are depressive episode, and / or manic / hypomanic episode, also can be mood stable；
- 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)；
- Currently according to diagnostic criteria of the U.S Diagnostic and Statistical Manual Fourth Edition of Mental Disease (DSM-IV) of depressive disorder；
Key exclusion criteria (4 listed)
- Can not understand the content of assessment and cooperate；
- Meet the diagnosis criteria of schizophrenia and other psychotic disorders;
- Meet the diagnosis criteria of Diagnosis of mental retardation or pervasive developmental disorder;
- Clinically significant neurological disease or loss of consciousness more than one hour of traumatic brain injury；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test-retest reliability of the scale
Time frame: one year later
1 secondary outcome
Cronbach's α coefficient of the scale
Time frame: one year later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Derived from this study: PubMed 27286368Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Unipolar Disorder, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest reliability of the scale (time frame: one year later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02015143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.