By InvitationNot Applicable

Digital Phenotypes for Predicting Depression

South Korea540 participantsStarted 2025-02-27

Plain-language summary

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.

Who can participate

Age range19 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults aged 19 to 75 years and 11 months.
✓. Diagnosed with a major mood disorder (bipolar I or II disorder, or major depressive disorder) based on DSM-5, with a history of psychiatric visits for mood symptoms.
✓. Has experienced at least one prior depressive episode (major, minor, or brief).
✓. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period.
✓. Adults aged 19 to 75 years and 11 months.
✓. No current or past diagnosis of bipolar disorder or major depressive disorder.
✓. Scores below clinical thresholds on both K-MDQ (\<7) and PHQ-9 (\<5) at baseline assessment.
✓. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period.

Exclusion criteria

What they're measuring

The Patient Health Questionnaire (PHQ-9)

Timeframe: Baseline, month 3, month 6, month 9, month 12

Inter-visit mood episode occurance

Timeframe: month 3, month 6, month 9, month 12

MADRS (Montgomery-Åsberg Depression Rating Scale)

Timeframe: Baseline, month 3, month 6, month 9, month 12

YMRS (Young Mania Rating Scale)

Timeframe: Baseline, month 3, month 6, month 9, month 12

CGI (Clinical Global Impression Scale)

Timeframe: Baseline, month 3, month 6, month 9, month 12

Trial details

NCT IDNCT07151846

SponsorKorea University Anam Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-31

View on ClinicalTrials.gov More Depression - Major Depressive Disorder trials

Plain-language summary

Who can participate

Age range19 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults aged 19 to 75 years and 11 months.
✓. Diagnosed with a major mood disorder (bipolar I or II disorder, or major depressive disorder) based on DSM-5, with a history of psychiatric visits for mood symptoms.
✓. Has experienced at least one prior depressive episode (major, minor, or brief).
✓. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period.
✓. Adults aged 19 to 75 years and 11 months.
✓. No current or past diagnosis of bipolar disorder or major depressive disorder.
✓. Scores below clinical thresholds on both K-MDQ (\<7) and PHQ-9 (\<5) at baseline assessment.
✓. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period.

Exclusion criteria

What they're measuring

The Patient Health Questionnaire (PHQ-9)

Timeframe: Baseline, month 3, month 6, month 9, month 12

Inter-visit mood episode occurance

Timeframe: month 3, month 6, month 9, month 12

MADRS (Montgomery-Åsberg Depression Rating Scale)

Timeframe: Baseline, month 3, month 6, month 9, month 12

YMRS (Young Mania Rating Scale)

Timeframe: Baseline, month 3, month 6, month 9, month 12

CGI (Clinical Global Impression Scale)

Timeframe: Baseline, month 3, month 6, month 9, month 12