Efficacy of the Mobile Application for Prediction and Prevention of Mood Episode Recurrence Based on Machine Learning

Not Applicable

Completed

• Conditions: Major Depressive Disorder; Bipolar 1 Disorder; Bipolar II Disorder

• Registration Number: NCT05400785
• Lead Sponsor: Hucircadian

Brief Summary

This study was designed to evaluate the efficacy of the mobile application named Circadian Rhythm for Mood (CRM), which was developed to prevent recurring episodes of mood disorders (major depressive disorders, bipolar disorders type 1 and 2) based on machine learning.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-27
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-02
• Primary Completion: 2023-12-21
• Study Completion: 2023-12-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• Male and female patients, 19-70 years old
• Diagnosis with Bipolar I disorder, Bipolar II disorder, Major depressive disorder based on DSM-5 criteria, in euthymic state for more than two weeks at the time of the recruitment
• Android smartphone users, capable of installing and executing the CRM application
• Consent to wear wearable device (Fitbit) continuously and synchronize and backup data regularly

Exclusion Criteria

• Patients who have not experienced major depressive, manic, or hypomanic episode in the last two years
• Patients who are difficult to specify mood episode or evaluate symptoms of mood episode independently due to personality traits (borderline personality trait, cyclothymic temperament, etc.)
• Patients with degenerative neurological disorders (Parkinson's disease, dementia, Huntington's disease, etc.), neurodevelopmental disorders (intellectual disorder, autism spectrum disorder, down syndrome, etc.), epilepsy, severe traumatic brain damage, stroke, and other brain neurological disorders
• Inmates or patients who are forced into custody for the treatment of mental or physical illness (non-voluntary isolation or hospitalization)
• Patients with difficulties in understanding the objectives and process of the study and the potential benefits and risks of participating in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of duration of mood episodes between the active and sham groups	12 months	We aim to evaluate the efficacy of reducing duration of mood episodes through the CRM mobile application.
Comparison of total number of recurrent mood episodes between the active and sham groups	12 months	We aim to evaluate the efficacy of reducing recurrence rate of mood episodes through the CRM mobile application.

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of