Status:
ENROLLING_BY_INVITATION
Digital Phenotypes for Predicting Depression
Lead Sponsor:
Korea University Anam Hospital
Collaborating Sponsors:
Korea University Medicine
Hucircadian
Conditions:
Depression - Major Depressive Disorder
Depression Bipolar
Eligibility:
All Genders
19-75 years
Brief 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...
Detailed Description
This is a 12-month longitudinal follow-up study designed to identify digital phenotypes capable of predicting the recurrence of major depressive episodes using passively collected real-time data from ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Patient Group:
- 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.
- Inclusion Criteria for Healthy Control Group:
- 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.
- Inclusion Criteria for Hight Risk Group:
- Adults aged 19 to 75 years and 11 months.
- No current or past diagnosis of bipolar disorder or major depressive disorder.
- Meets either of the following:
- A. Scores above the threshold on K-MDQ (≥7) or PHQ-9 (≥5) at baseline. B. Reports persistent mood symptoms during MINI (e.g., ≥2 weeks of depressive mood/anhedonia, or several days of elevated/irritable mood).
- 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 Critera (Overall)
- Inability to provide informed consent due to cognitive impairment, severe psychiatric symptoms, or language barriers.
- Presence of any neurological or medical condition that may significantly affect mood, cognition, or behavior (e.g., epilepsy, dementia, traumatic brain injury).
- Current substance use disorder or dependence (excluding nicotine or caffeine) that is either untreated or clinically unstable.
- Severe suicidal ideation or risk as determined by clinical judgment at screening.
- Ongoing participation in another interventional clinical trial, particularly those involving psychotropic medications or digital health interventions.
- Inability or unwillingness to wear a wearable device (Fitbit) or use the required mobile application daily throughout the study.
- Lack of stable internet access or a compatible smartphone required for digital phenotyping data collection.
- Any other condition that, in the investigator's judgment, may compromise the participant's safety, compliance, or the integrity of the study data.
Exclusion
Key Trial Info
Start Date :
February 27 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT07151846
Start Date
February 27 2025
End Date
August 31 2026
Last Update
September 3 2025
Active Locations (1)
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1
Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea, 02841