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Digital Phenotypes for Predicting Depression_Validation
Sponsor: Korea University Anam Hospital
Summary
This 12-month, single-site prospective observational study will prospectively monitor the recurrence of mood episodes while continuously collecting passive digital phenotypes in individuals with and without mood disorders. A total of 200 adults will be enrolled, including 100 patients with major depressive disorder or bipolar I/II disorder and 100 healthy control participants. Participants will complete five clinical assessments at 3-month intervals and will continuously wear a consumer wearable device and use the My Mental HERO smartphone application for passive sensing and daily mood recording. Structured clinical interviews will identify the occurrence, subtype, and day-level onset and offset of mood episodes during follow-up. The study will examine longitudinal digital phenotypes associated with mood states and subsequent mood episode onset. It is designed to provide an independent validation dataset for digital phenotypes and prediction models developed in the preceding MentalHERO prospective observational cohort (ClinicalTrials.gov Identifier: NCT07151846). Because the two cohorts follow closely aligned study protocols and assessment schedules, data from both cohorts may also be pooled for secondary analyses where appropriate.
Official title: Discovery and Validation of Digital Phenotypes for Predicting Recurrence of Depressive Episodes_Validation Set Collection
Key Details
Gender
All
Age Range
19 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-05-13
Completion Date
2027-10-30
Last Updated
2026-10-19
Healthy Volunteers
Yes
Locations (1)
Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea