Digital Phenotypes for Predicting Depression (NCT07151846) | Clinical Trial Compass
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 range
19 Years – 75 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. 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.