Bipolar Disorder and Oxidative Stress Injury Mechanism - Clinical Big Data Analysis Based on Machine Learning

Bipolar Disorder Clinical Trial

Official title:

Bipolar Disorder and Oxidative Stress Injury Mechanism - Clinical Big Data Analysis Based on Machine Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949218
• Other study ID #: CRC2018DSJ01-1
• Status: Completed
• Start date: November 20, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: May 2019
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a single-center, retrospective, cross-sectional study. We plan to work with our network information center to analysis the related indicators of oxidative stress injury in patients with bipolar disorder based on oxidative stress data. During the study, machine learning was used as a data analysis method to screen out the biomarker risk factors with sensitivity and specificity for early recognition of bipolar disorder from major depression disorder with oxidative stress injury as the core. And then build up effective clinical predictive models for early identification of bipolar disorder, which can predict the early quantitative probabilistic of the onset of bipolar disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3702
• Est. completion date: November 20, 2018
• Est. primary completion date: November 20, 2018
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• age is not limited

• gender is not limited

• meets the diagnostic criteria for bipolar disorder of ICD-10 F31,F32 and its sub-categories

• has relevant HIS system data that can be utilized.

Exclusion Criteria:

• patients who did not meet the appeal diagnosis after three-level rounds of ward

• patients who met the above three diagnoses but had severe data loss (missing value = estimated data value of 30%)

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

References & Publications (3)

Fang Y, Yuan C, Xu Y, Chen J, Wu Z, Cao L, Yi Z, Hong W, Wang Y, Jiang K, Cui X, Calabrese JR, Gao K; OPERATION Study Team. A pilot study of the efficacy and safety of paroxetine augmented with risperidone, valproate, buspirone, trazodone, or thyroid horm — View Citation

Guo X, Li Z, Zhang C, Yi Z, Li H, Cao L, Yuan C, Hong W, Wu Z, Peng D, Chen J, Xia W, Zhao G, Wang F, Yu S, Cui D, Xu Y, Golam CM, Smith AK, Wang T, Fang Y. Down-regulation of PRKCB1 expression in Han Chinese patients with subsyndromal symptomatic depress — View Citation

Zhang C, Lu W, Wang Z, Ni J, Zhang J, Tang W, Fang Y. A comprehensive analysis of NDST3 for schizophrenia and bipolar disorder in Han Chinese. Transl Psychiatry. 2016 Jan 5;6:e701. doi: 10.1038/tp.2015.199. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early prediction model of bipolar disorder with oxidative stress index as the core	Based on the oxidative stress data, the study will analysis related indicators of oxidative stress injury in patients with bipolar disorder. Then use the method of machine learning to build up the early prediction model of bipolar disorder.	at August 2019