NCT07151846Enrolling by invitation

Digital Phenotypes for Predicting Depression

Discovery and Validation of Digital Phenotypes for Predicting Recurrence of Depressive Episodes

Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Enrolling by invitation
Study type: Observational
Enrollment: 540 (estimated)
First submitted: 23 Jul 2025
Start date: 27 Feb 2025
Primary completion date: 31 Aug 2026
Lead sponsor: Korea University Anam Hospital
Diseases: Depression, Bipolar disorder
NCT number: NCT07151846

What you commit to

Study type: Observational
Planned participants: 540
From 27 Feb 2025 to the primary completion date, 31 Aug 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

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.
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:
- 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.

Age in the registry: 19 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Korea University Anam Hospital Coordinator of this site? Confirm its status	Seoul	South Korea	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.