Depression - Major Depressive DisorderNCT07151846
Digital Phenotypes for Predicting Depression
An observational study of Depression - Major Depressive Disorder and Depression Bipolar, run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder, Depression Bipolar, Bipolar Disorder (BD)
- How many people
- 540 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Feb 2025to 31 Aug 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will recruit a total of 540 participants divided into three groups: Patient Group (PT, n=200): Individuals diagnosed with a mood disorder (bipolar I/II or major depressive disorder) who have experienced at least one depressive episode within the past two years. High-Risk Group (HR): Individuals with no formal mood disorder diagnosis but who present subclinical mood symptoms or elevated screening scores suggesting potential risk for affective disorders. Healthy Control Group (HC): Individuals with no history or current diagnosis of any mood disorder and who do not show clinically significant symptoms on screening assessments. All participants will undergo 5 clinical assessments over a 12-month period (every 3 months) and will be asked to wear a Fitbit device daily and record their mood daily via a mobile app throughout the study. No therapeutic intervention will be provided, and the study does not involve randomization or blinding.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841
About this study
Official title: Discovery and Validation of Digital Phenotypes for Predicting Recurrence of Depressive Episodes
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.
Read the 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 smartphones and wearable devices. A total of 540 participants will be enrolled, including 200 patients diagnosed with mood disorders who have experienced at least one depressive episode in the past two years, and 340 healthy or high-risk control participants without a clinical diagnosis.
Clinical interviews and self-report measures will be conducted five times at 3-month intervals. Throughout the study period, participants will wear a Fitbit device daily and use the "My Mental Hero" mobile application to record their mood once a day at a self-selected time. Data collected will be used to develop machine learning models for predicting depressive recurrence and to build a large-scale, anonymized wearable big-data repository for mood disorders.
Participants will receive no interventions beyond data collection, and neither randomization nor blinding will be implemented. Trained psychiatrists, clinical psychologists, or research nurses will conduct the assessments. Initial visits will include informed consent, device setup, and app training, taking approximately 1-2 hours. Subsequent assessments will take about one hour, with additional brief interviews (≤30 minutes) conducted if a mood episode is suspected.
While follow-up assessments for patients and high-risk participants will be conducted in person, those for healthy controls may be conducted remotely (via Zoom or phone) under secure and private conditions without screen recording. Remote assessments may also be used for patient and high-risk groups if necessary.
- Conditions
- Depression - Major Depressive Disorder, Depression Bipolar, Bipolar Disorder (BD), Mood Disorders
- Medical subject headings
- Bipolar Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Adults (19-75 years) with a clinical diagnosis of a major mood disorder (bipolar I/II or major depressive disorder) per DSM-5, with at least one prior depressive episode. | |
| High Risk | Adults (19-75 years) with no formal diagnosis of bipolar disorder or major depressive disorder, but who meet at least one of the following: 1. Elevated scores at screening (K-MDQ ≥7 or PHQ-9 ≥5), or 2. Report of persistent mood symptoms (e.g., ≥2 weeks of low mood or ≥several days of elevated/irritable mood) during MINI interview. | |
| Healthy Control | Adults (19-75 years) with no current or past diagnosis of bipolar disorder or major depressive disorder, and who screen below cutoff on both K-MDQ (<7) and PHQ-9 (<5). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a self-report screening tool designed to assess the severity of depressive symptoms. PHQ score range is 0 to 27. Higher PHQ score indicates worse depressive symptoms.
Measured: Baseline, month 3, month 6, month 9, month 12
Inter-visit mood episode occurance
Mood episodes that occur between scheduled study visits will be assessed by trained raters. If an inter-visit episode is suspected, a structured clinical evaluation will be conducted using standardized case report forms (CRFs) to determine:
- Episode period (start and end dates),
- Presence of DSM-5 mood symptoms (e.g., depressed mood, anhedonia, decreased need for sleep, inflated self-esteem),
- Episode severity as rated by the Clinical Global Impressions (CGI) scale (1-7; higher scores indicate greater severity).
Scoring and Interpretation:
- CGI scale range: 1 (Normal, not ill) to 7 (Among the most extremely ill patients).
- Higher CGI scores represent worse mood symptom severity.
Diagnostic criteria for depressive episodes (≥1 core symptom plus ≥5 symptoms, ≥2 weeks) and (hypo)manic episodes (≥1 core symptom plus ≥3-4 symptoms, ≥4 days) will be applied using the CRF.
Measured: month 3, month 6, month 9, month 12
MADRS (Montgomery-Åsberg Depression Rating Scale)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered tool used to assess the severity of depressive symptoms. It consists of 10 items rated on a 0-6 scale and is widely used in clinical trials due to its sensitivity to treatment-related change. MADRS score range is 0 to 60. Higher MADRS score indicates worse depressive symptoms.
Measured: Baseline, month 3, month 6, month 9, month 12
YMRS (Young Mania Rating Scale)
The Young Mania Rating Scale (YMRS) is a clinician-rated scale used to measure the severity of manic symptoms in individuals with bipolar disorder. It includes 11 items covering mood, behavior, and cognitive functioning, with higher scores indicating greater symptom severity. YMRS score rang is 0 to 60.
Higher YMRS score indicates worse manic symptoms.
Measured: Baseline, month 3, month 6, month 9, month 12
CGI (Clinical Global Impression Scale)
The Clinical Global Impression (CGI) Scale is a standardized assessment tool used by clinicians to rate overall illness severity (CGI-S). CGI-S is rated on a 7-point scale for each of three components: Depression, Mania, Overall. CGI scale range: 1 (Normal, not ill) to 7 (Among the most extremely ill patients).
Measured: Baseline, month 3, month 6, month 9, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start27 Feb 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Medicine, Hucircadian
- Responsible party
- Principal investigator, Heon-Jeong Lee, MD, PhD, Korea University Anam Hospital
- Investigators
- Heon-Jeong Lee, Professor, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151846
- Sponsor's protocol ID
- MY MENTAL HERO
- Other IDs
- RS-2024-00469788
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Some of the data will be shared with the K-BDS (Korea Brain Data Station) after the completion of the study; however, the exact amount and timing of data to be shared have not yet been determined. The expected date of upload to the K-BDS is December 31, 2027.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery and Validation of Digital Phenotypes for Predicting Recurrence of Depressive Episodes
- ClinicalTrials.gov ID
- NCT07151846
- Acronym / sponsor ID
- MY MENTAL HERO
- Conditions
- Depression - Major Depressive Disorder, Depression Bipolar, Bipolar Disorder (BD), Mood Disorders
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Korea University Medicine, Hucircadian
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 smartphones and wearable devices. A total of 540 participants will be enrolled, including 200 patients diagnosed with mood disorders who have experienced at least one depressive episode in the past two years, and 340 healthy or high-risk control participants without a clinical diagnosis.
Clinical interviews and self-report measures will be conducted five times at 3-month intervals. Throughout the study period, participants will wear a Fitbit device daily and use the "My Mental Hero" mobile application to record their mood once a day at a self-selected time. Data collected will be used to develop machine learning models for predicting depressive recurrence and to build a large-scale, anonymized wearable big-data repository for mood disorders.
Participants will receive no interventions beyond data collection, and neither randomization nor blinding will be implemented. Trained psychiatrists, clinical psychologists, or research nurses will conduct the assessments. Initial visits will include informed consent, device setup, and app training, taking approximately 1-2 hours. Subsequent assessments will take about one hour, with additional brief interviews (≤30 minutes) conducted if a mood episode is suspected.
While follow-up assessments for patients and high-risk participants will be conducted in person, those for healthy controls may be conducted remotely (via Zoom or phone) under secure and private conditions without screen recording. Remote assessments may also be used for patient and high-risk groups if necessary.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | –Adults (19-75 years) with a clinical diagnosis of a major mood disorder (bipolar I/II or major depressive disorder) per DSM-5, with at least one prior depressive episode. |
| High Risk | – | –Adults (19-75 years) with no formal diagnosis of bipolar disorder or major depressive disorder, but who meet at least one of the following: 1. Elevated scores at screening (K-MDQ ≥7 or PHQ-9 ≥5), or 2. Report of persistent mood symptoms (e.g., ≥2 weeks of low mood or ≥several days of elevated/irritable mood) during MINI interview. |
| Healthy Control | – | –Adults (19-75 years) with no current or past diagnosis of bipolar disorder or major depressive disorder, and who screen below cutoff on both K-MDQ (<7) and PHQ-9 (<5). |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit a total of 540 participants divided into three groups: Patient Group (PT, n=200): Individuals diagnosed with a mood disorder (bipolar I/II or major depressive disorder) who have experienced at least one depressive episode within the past two years. High-Risk Group (HR): Individuals with no formal mood disorder diagnosis but who present subclinical mood symptoms or elevated screening scores suggesting potential risk for affective disorders. Healthy Control Group (HC): Individuals with no history or current diagnosis of any mood disorder and who do not show clinically significant symptoms on screening assessments. All participants will undergo 5 clinical assessments over a 12-month period (every 3 months) and will be asked to wear a Fitbit device daily and record their mood daily via a mobile app throughout the study. No therapeutic intervention will be provided, and the study does not involve randomization or blinding.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, month 3, month 6, month 9, month 12
The Patient Health Questionnaire (PHQ-9) is a self-report screening tool designed to assess the severity of depressive symptoms. PHQ score range is 0 to 27. Higher PHQ score indicates worse depressive symptoms.
Inter-visit mood episode occurance
Time frame: month 3, month 6, month 9, month 12
Mood episodes that occur between scheduled study visits will be assessed by trained raters. If an inter-visit episode is suspected, a structured clinical evaluation will be conducted using standardized case report forms (CRFs) to determine: 1. Episode period (start and end dates), 2. Presence of DSM-5 mood symptoms (e.g., depressed mood, anhedonia, decreased need for sleep, inflated self-esteem), 3. Episode severity as rated by the Clinical Global Impressions (CGI) scale (1-7; higher scores indicate greater severity). Scoring and Interpretation: * CGI scale range: 1 (Normal, not ill) to 7 (Among the most extremely ill patients). * Higher CGI scores represent worse mood symptom severity. Diagnostic criteria for depressive episodes (≥1 core symptom plus ≥5 symptoms, ≥2 weeks) and (hypo)manic episodes (≥1 core symptom plus ≥3-4 symptoms, ≥4 days) will be applied using the CRF.
MADRS (Montgomery-Åsberg Depression Rating Scale)
Time frame: Baseline, month 3, month 6, month 9, month 12
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered tool used to assess the severity of depressive symptoms. It consists of 10 items rated on a 0-6 scale and is widely used in clinical trials due to its sensitivity to treatment-related change. MADRS score range is 0 to 60. Higher MADRS score indicates worse depressive symptoms.
YMRS (Young Mania Rating Scale)
Time frame: Baseline, month 3, month 6, month 9, month 12
The Young Mania Rating Scale (YMRS) is a clinician-rated scale used to measure the severity of manic symptoms in individuals with bipolar disorder. It includes 11 items covering mood, behavior, and cognitive functioning, with higher scores indicating greater symptom severity. YMRS score rang is 0 to 60. Higher YMRS score indicates worse manic symptoms.
CGI (Clinical Global Impression Scale)
Time frame: Baseline, month 3, month 6, month 9, month 12
The Clinical Global Impression (CGI) Scale is a standardized assessment tool used by clinicians to rate overall illness severity (CGI-S). CGI-S is rated on a 7-point scale for each of three components: Depression, Mania, Overall. CGI scale range: 1 (Normal, not ill) to 7 (Among the most extremely ill patients).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Undecided. Some of the data will be shared with the K-BDS (Korea Brain Data Station) after the completion of the study; however, the exact amount and timing of data to be shared have not yet been determined. The expected date of upload to the K-BDS is December 31, 2027.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heon-Jeong Lee, Professor principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder and Depression Bipolar, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Patient Health Questionnaire (PHQ-9) (time frame: Baseline, month 3, month 6, month 9, month 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.