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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05400785
Other study ID # HC-CRM-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 27, 2022
Est. completion date October 31, 2023

Study information

Verified date December 2022
Source Hucircadian
Contact Heon-Jeong Lee, MD, PhD
Phone +82 10 4529 5653
Email leehjeong@korea.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date October 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility 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


Intervention

Other:
Circadian Rhythms for Mood (CRM) application - Active
The study subjects participating in this clinical trial wear wearable activity tracker 24 hours a day for a continuous period of time and run the CRM app once a day to check their conditions (feelings, vitality, sleep, etc.) in the Daily Symptom Assessment (eMoodChart). The active intervention group are provided with mood prediction results and instructions as feedback through the 'life report' and push notification in the application.
Circadian Rhythms for Mood (CRM) application - Sham
The study subjects assigned to the sham intervention group are provided with feedbacks operated by dummy algorithm. The application is visually indistinguishable from active CRM, and it is designed to minimize behavioral change.

Locations

Country Name City State
Korea, Republic of Korea University Anam Hospital Seoul

Sponsors (5)

Lead Sponsor Collaborator
Hucircadian Inje University Ilsan Paik Hospital, Korea University Ansan Hospital, Korea University Guro Hospital, Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of total number of recurrent mood episodes between the active and sham groups We aim to evaluate the efficacy of reducing recurrence rate of mood episodes through the CRM mobile application. 12 months
Primary Comparison of duration of mood episodes between the active and sham groups We aim to evaluate the efficacy of reducing duration of mood episodes through the CRM mobile application. 12 months
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