Prediction on the Recurrence of Manic and Depressive Episodes in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Prediction on the Recurrence of Manic and Depressive Episodes in Bipolar Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828056
• Other study ID #: 202002006RINA
• Status: Recruiting
• Start date: March 2, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: National Taiwan University Hospital
• Contact: Yi-Ling Chien
• Phone: +886223123456#66013
• Email: chienyiling[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Mood disorders (including bipolar disorder and major depressive disorder) are chronic mental disorders with high recurrent rate. The more the number of recurrence is, the worse long-term prognosis is. This study aims to establish a prediction model of recurrence of manic and depressive episodes in mood disorders, with a hope to detect recurrence relapse as early as possible for timely clinical intervention. We will adopt wearable smart watch to collect heart rate, sleep pattern, activity level, as well as emotional status for one year long in 100 patients with bipolar disorder, and annotated their mood status (i.e., manic episode, depressive episode, and euthymic state). We expect to establish prediction models to predict the recurrence of mood episodes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• DSM-5 Bipolar disorder or depressive disorder

• 20~60 years old

• Willing to carry smartwatch and smartphone most of the time

Exclusion Criteria:

• Comorbid with substance use disorder

• Unable to use smartwatch and smartphone

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Disease
• Recurrence

Intervention

Device:
• Wearable activity tracker
Garmin smartwatch will record features, such as activities, heart rate, sleep, through smartphone App

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development and verification of mood episode prediction algorithm	Collected data will apply to learning algorithm, random forest, which constructs a multitude of decision trees at training time and outputting a class that is the mode of the classes of the individual trees. Performance of the trained prediction model was evaluated by assessing the model's accuracy, sensitivity, specificity, and the area under the curve. In a machine learning evaluation process, a part of data is used for model training, and the other portion is used for model testing.	1 year