NCT01770704

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.4 years

First QC Date

January 16, 2013

Last Update Submit

April 6, 2016

Conditions

Bipolar Disorder

Keywords

Bipolar disorderClinical managementClinical outcomes

Outcome Measures

Primary Outcomes (1)

  • Number of episodes (depression, mania, hypomania or mixed).

    Up to 21 months

Secondary Outcomes (2)

  • Treatments received for Bipolar Disorder: medication time.

    Up to 21 months

  • Treatments received for Bipolar Disorder: medication classes.

    Up to 21 months

Study Arms (1)

Patients diagnosed with bipolar disorder I or II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Shenzhen, Guangdong, China

Location

Reserach Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Xi’an, Shanxi, China

Location

Research SIte

Kunming, Yunnan, China

Location

Research Site

Hangzhou, Zhejiang, China

Location

Related Publications (4)

  • 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.

    PMID: 38592605DERIVED

  • 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.

    PMID: 37275983DERIVED

  • 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.

    PMID: 37226150DERIVED

  • 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.

    PMID: 27825780DERIVED

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Yu Xin

    Beijing No.6 Hospital

    PRINCIPAL INVESTIGATOR

  • Wang Gang

    Capital Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

CN(6)