Bipolar DisorderNCT01770704
Observation Study of the Clinical Management of Bipolar Disorder
An observational study of Bipolar Disorder, run by AstraZeneca at 6 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- How many people
- 520 participants
- Where
- 6 sitesChina
- Study dates
- Feb 2013to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with bipolar disorder I or II with at least one mood event during the 3 and 12 months prior to the beginning of the study.
Who may be able to join
- 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.
Who cannot join
- Inability to complete Patient Reported Outcomes (PROs) questionnaires.
- Participation in an interventional clinical study in last 12 months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Research Site
Beijing, Beijing Municipality
Research Site
Hangzhou, Zhejiang
Research SIte
Kunming, Yunnan
Reserach Site
Shanghai, Shanghai Municipality
Research Site
Shenzhen, Guangdong
Research Site
Xi’an, Shanxi
About this study
Official title: Chinese 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.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, Clinical management, Clinical outcomes
- 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 |
|---|---|---|
| Patients diagnosed with bipolar disorder I or II | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes (depression, mania, hypomania or mixed).
Measured: Up to 21 months
Secondary outcomes (2)
Treatments received for Bipolar Disorder: medication time.
Measured: Up to 21 months
Treatments received for Bipolar Disorder: medication classes.
Measured: Up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 AstraZenecaThe 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
- Observational model
- Cohort
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Xin, Principal investigator, Beijing No.6 HospitalWang Gang, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770704
- Sponsor's protocol ID
- NIS-NCN-XXX-2012/1
- Status last verified
- Apr 2016
- First submitted
- 16 Jan 2013
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Xu JJ, Zhu XQ, Liu S, Ding LY, Fu BB, Sun CC, Pan YL, Wang W, Zhang L. Sociodemographic, clinical and treatment characteristics of current rapid-cycling bipolar disorder: a multicenter Chinese study. Int J Bipolar Disord. 2024 Apr 9;12(1):11. doi: 10.1186/s40345-024-00332-z.
PubMed 38592605Shi X, Zhao Y, Yang H, Xu X, Fang Y, Yu X, Tan Q, Li H, Sun G, Wu H, Wang P, Yang J, Zhu X, Wang G, Zhang L. Factors associated with hospitalization times and length of stay in patients with bipolar disorder. Front Psychiatry. 2023 May 19;14:1140908. doi: 10.3389/fpsyt.2023.1140908. eCollection 2023.
PubMed 37275983Zhang ZF, Huang J, Zhu XQ, Yu X, Yang HC, Xu XF, Fang YR, Tan QR, Li HC, Wang G, Zhang L. Clinicodemographic correlates of psychotic features in bipolar disorder - a multicenter study in China. BMC Psychiatry. 2023 May 24;23(1):365. doi: 10.1186/s12888-023-04761-5.
PubMed 37226150Zhang L, Yang HC, Xu XF, Fang YR, Yu X, Tan QR, Li HC, Ungvari GS, Ng CH, Wang G, Xiang YT. Demographic and clinical differences between early- and late-onset bipolar disorders in a multicenter study in China. Psychiatry Res. 2016 Dec 30;246:688-691. doi: 10.1016/j.psychres.2016.10.063. Epub 2016 Oct 30.
PubMed 27825780
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Observation Study of the Clinical Management of Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01770704
- Acronym / sponsor ID
- NIS-NCN-XXX-2012/1
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, Clinical management, Clinical outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Jan 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 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.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with bipolar disorder I or II | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with bipolar disorder I or II with at least one mood event during the 3 and 12 months prior to the beginning of the study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to complete Patient Reported Outcomes (PROs) questionnaires.
- Participation in an interventional clinical study in last 12 months.
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
Number of episodes (depression, mania, hypomania or mixed).
Time frame: Up to 21 months
2 secondary outcomes
Treatments received for Bipolar Disorder: medication time.
Time frame: Up to 21 months
Treatments received for Bipolar Disorder: medication classes.
Time frame: Up to 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Derived from this study: PubMed 38592605Xu JJ, Zhu XQ, Liu S, Ding LY, Fu BB, Sun CC, Pan YL, Wang W, Zhang L. Sociodemographic, clinical and treatment characteristics of current rapid-cycling bipolar disorder: a multicenter Chinese study. Int J Bipolar Disord. 2024 Apr 9;12(1):11. doi: 10.1186/s40345-024-00332-z.
- Derived from this study: PubMed 37275983Shi X, Zhao Y, Yang H, Xu X, Fang Y, Yu X, Tan Q, Li H, Sun G, Wu H, Wang P, Yang J, Zhu X, Wang G, Zhang L. Factors associated with hospitalization times and length of stay in patients with bipolar disorder. Front Psychiatry. 2023 May 19;14:1140908. doi: 10.3389/fpsyt.2023.1140908. eCollection 2023.
- Derived from this study: PubMed 37226150Zhang ZF, Huang J, Zhu XQ, Yu X, Yang HC, Xu XF, Fang YR, Tan QR, Li HC, Wang G, Zhang L. Clinicodemographic correlates of psychotic features in bipolar disorder - a multicenter study in China. BMC Psychiatry. 2023 May 24;23(1):365. doi: 10.1186/s12888-023-04761-5.
- Derived from this study: PubMed 27825780Zhang L, Yang HC, Xu XF, Fang YR, Yu X, Tan QR, Li HC, Ungvari GS, Ng CH, Wang G, Xiang YT. Demographic and clinical differences between early- and late-onset bipolar disorders in a multicenter study in China. Psychiatry Res. 2016 Dec 30;246:688-691. doi: 10.1016/j.psychres.2016.10.063. Epub 2016 Oct 30.
- NIS-NCN-XXX-2012\_1-Bipolar Disorder in China\_NISR\_20151126 CSR SynopsisLink provided by the sponsor.
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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.
Yu Xin principal investigator
Beijing No.6 Hospital
Wang Gang principal investigator
Capital Medical University
6 sites 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, run by AstraZeneca at 6 sites 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of episodes (depression, mania, hypomania or mixed). (time frame: Up to 21 months). 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 NCT01770704, which also lists 4 linked publications.
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 7 Apr 2016.