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CompletedNCT05400785Updated Mar 17, 2025

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

An interventional study of Circadian Rhythms for Mood (CRM) application - Active and Circadian Rhythms for Mood (CRM) application - Sham in Major Depressive Disorder, Bipolar 1 Disorder and Bipolar II Disorder, sponsored by Hucircadian. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Hucircadian · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
19 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder
  • Bipolar 1 Disorder
  • Bipolar II Disorder
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 93 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

This is the only study on the registry with Hucircadian as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
93 participants (actual)

Study arms

  • Active comparator
    Active CRM

    Other: Circadian Rhythms for Mood (CRM) application - Active

  • Sham comparator
    Sham CRM

    Other: Circadian Rhythms for Mood (CRM) application - Sham

Interventions

  • OtherCircadian 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.

  • OtherCircadian 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

07

Study locations

1 site
  • Korea University Anam Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05400785
Lead sponsor
Hucircadian
Collaborators
Korea University Guro Hospital, Korea University Ansan Hospital, Pusan National University Hospital, Inje University Ilsan Paik Hospital
Responsible party
Sponsor
First posted
Jun 2, 2022
Start date
May 27, 2022
Primary completion
Dec 21, 2023
Completion
Dec 21, 2023
Last update
Mar 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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