Digital Phenotypes for Predicting Depression

Sponsor
Korea University Anam Hospital
Study ID
NCT07151846
Status
Enrolling By Invitation

Conditions

  • Bipolar Disorder (BD)
  • Depression - Major Depressive Disorder
  • Depression Bipolar
  • Mood Disorders

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Accepted

Study Details

This longitudinal study aims to identify and validate digital phenotypes that can predict recurrence of major depressive episodes using passively collected, real-time sensing data from smartphones and wearable devices. Over a 12-month period, 540 participants-including patients with mood disorders and healthy or high-risk controls-will complete five clinical assessments at 3-month intervals, wear a Fitbit device daily, and log daily mood ratings via a mobile app. The study includes the development of AI-based predictive models and the construction of an anonymized wearable big-data repository for mood disorders.

Key Dates

First listed
Sep 3, 2025
Start date
Feb 27, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
540 participants (estimated)

Arms

  • Arm: Patient group
    Adults (19-75 years) with a clinical diagnosis of a major mood disorder (bipolar I/II or major depressive disorder) per DSM-5, with at least one prior depressive episode.
  • Arm: High Risk
    Adults (19-75 years) with no formal diagnosis of bipolar disorder or major depressive disorder, but who meet at least one of the following: 1. Elevated scores at screening (K-MDQ ≥7 or PHQ-9 ≥5), or 2. Report of persistent mood symptoms (e.g., ≥2 weeks of low mood or ≥several days of elevated/irritable mood) during MINI interview.
  • Arm: Healthy Control
    Adults (19-75 years) with no current or past diagnosis of bipolar disorder or major depressive disorder, and who screen below cutoff on both K-MDQ (\<7) and PHQ-9 (\<5).

Primary Outcome Measure

The Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, month 3, month 6, month 9, month 12 ]

Related Studies