Observation Study of the Clinical Management of Bipolar Disorder

NCT ID: NCT01770704

Last Updated: 2016-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients diagnosed with bipolar disorder I or II

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Inability to complete Patient Reported Outcomes (PROs) questionnaires.
* Participation in an interventional clinical study in last 12 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yu Xin

Role: PRINCIPAL_INVESTIGATOR

Beijing No.6 Hospital

Wang Gang

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Beijing, Beijing Municipality, China

Site Status

Research Site

Shenzhen, Guangdong, China

Site Status

Reserach Site

Shanghai, Shanghai Municipality, China

Site Status

Research Site

Xi’an, Shanxi, China

Site Status

Research SIte

Kunming, Yunnan, China

Site Status

Research Site

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38592605 (View on PubMed)

Shi 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.

Reference Type DERIVED
PMID: 37275983 (View on PubMed)

Zhang 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.

Reference Type DERIVED
PMID: 37226150 (View on PubMed)

Zhang 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.

Reference Type DERIVED
PMID: 27825780 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIS-NCN-XXX-2012/1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bipolar Disorder Study for Men and Women
NCT00056277 COMPLETED PHASE3