Major Depressive DisorderNCT07880015
Digital Phenotypes for Predicting Depression_Validation
An observational study of Major Depressive Disorder and Bipolar I Disorder, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
This 12-month, single-site prospective observational study will prospectively monitor the recurrence of mood episodes while continuously collecting passive digital phenotypes in individuals with and without mood disorders. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Bipolar I Disorder, Bipolar II Disorder
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2026to 30 Oct 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
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 prospective observational study will enroll 200 adults aged 19-75 years, comprising 100 patients with mood disorders and 100 healthy control participants. The patient group will include individuals with DSM-5 major depressive disorder, bipolar I disorder, or bipolar II disorder who have experienced at least one major depressive episode. The healthy control group will include individuals with no current or past diagnosis of major depressive disorder or bipolar disorder, a baseline PHQ-9 score <5, and no past or current persistent mood symptoms. Both groups will participate in the same 12-month prospective follow-up, including continuous wearable- and smartphone-based digital phenotyping and scheduled clinical assessments at 3-month intervals. Participants are recruited at Korea University Anam Hospital and affiliated recruitment settings according to the prespecified eligibility criteria.
Who may be able to join
None listed.
Who cannot join
- Has experienced symptoms suggestive of depression or bipolar disorder in the past but has never received a psychiatric diagnosis for these symptoms.
- Has a history of moderate or severe intellectual disability.
- Has a current or past history of head trauma associated with loss of consciousness, a degenerative neurological disease, or an organic neurological disorder, including stroke, epilepsy, traumatic brain injury, multiple sclerosis, Alzheimer's disease, or Parkinson's disease.
- Has difficulty reading or understanding Korean.
- Has difficulty using a smartphone to an extent that may interfere with study participation, or does not have continuous internet access through the smartphone.
- Is judged by the principal investigator to have difficulty identifying mood episodes or independently evaluating mood-episode symptoms.
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- Healthy control group
- Has past or current persistent mood symptoms, defined as depressed mood or loss of interest lasting at least 2 weeks, or elevated or irritable mood lasting several days or longer.
- Has a history of psychiatric consultation or treatment, including for psychiatric conditions other than major depressive disorder or bipolar disorder.
- Has a baseline PHQ-9 score ≥5.
- Has a history of moderate or severe intellectual disability.
- Has a current or past history of head trauma associated with loss of consciousness, a degenerative neurological disease, or an organic neurological disorder, including stroke, epilepsy, traumatic brain injury, multiple sclerosis, Alzheimer's disease, or Parkinson's disease.
- Has difficulty reading or understanding Korean.
- Has difficulty using a smartphone to an extent that may interfere with study participation, or does not have continuous internet access through the smartphone.
- Is judged by the principal investigator to have difficulty identifying mood episodes or independently evaluating mood-episode symptoms.
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_Validation Set Collection
This 12-month, single-site prospective observational study will prospectively monitor the recurrence of mood episodes while continuously collecting passive digital phenotypes in individuals with and without mood disorders. A total of 200 adults will be enrolled, including 100 patients with major depressive disorder or bipolar I/II disorder and 100 healthy control participants. Participants will complete five clinical assessments at 3-month intervals and will continuously wear a consumer wearable device and use the My Mental HERO smartphone application for passive sensing and daily mood recording. Structured clinical interviews will identify the occurrence, subtype, and day-level onset and offset of mood episodes during follow-up.
The study will examine longitudinal digital phenotypes associated with mood states and subsequent mood episode onset. It is designed to provide an independent validation dataset for digital phenotypes and prediction models developed in the preceding MentalHERO prospective observational cohort (ClinicalTrials.gov Identifier: NCT07151846). Because the two cohorts follow closely aligned study protocols and assessment schedules, data from both cohorts may also be pooled for secondary analyses where appropriate.
Read the detailed description
This is a single-site, 12-month prospective observational study conducted at Korea University Anam Hospital. A total of 200 participants will be enrolled, including 100 patients with DSM-5 major depressive disorder, bipolar I disorder, or bipolar II disorder and 100 healthy control participants.
Participants will be classified into the patient or comparison group according to prespecified eligibility criteria, and both groups will undergo the same 12-month prospective follow-up. Throughout the study, participants will continuously wear a Fitbit Charge 6 and will complete five scheduled clinical assessments at baseline and months 3, 6, 9, and 12.
Clinical assessments will include structured diagnostic and mood-episode interviews, clinician-rated measures of depressive and manic symptom severity, and self-report assessments of mood, sleep, circadian rhythms, anxiety, functioning, and related clinical characteristics.
Throughout the study period, participants will continuously use the My Mental HERO smartphone application in conjunction with the wearable device. Passive digital phenotypes will include heart rate, heart-rate variability, sleep, physical activity, GPS, ambient light, smartphone use, and communication-related metadata. Participants will also complete a brief daily eMoodChart assessing mood, energy, anxiety, irritability, alcohol use, medication adherence, and menstrual-cycle status where applicable.
At each follow-up assessment, a structured mood-episode interview will be conducted to identify mood episodes occurring since the previous visit. For each suspected episode, trained raters will establish onset and offset dates, assess DSM-5 criterion symptoms and functional impairment, determine the predominant mood pole, document relevant specifiers, and assign an episode-level Clinical Global Impression rating. Episode classifications will be adjudicated using available clinical records, eMoodChart data, and other clinical information.
The primary scientific objective of the study is to characterize digital phenotypes associated with mood episodes and to evaluate whether passive behavioral and physiological features can identify mood states and predict clinician-adjudicated mood episode onset. The dataset is specifically intended to serve as an independent validation cohort for digital phenotypes and prediction models developed in the preceding MentalHERO prospective observational cohort (ClinicalTrials.gov Identifier: NCT07151846). Because the present study uses a closely aligned design, assessment schedule, clinical evaluation framework, and digital phenotyping protocol, data from the two cohorts may also be pooled for secondary analyses when scientifically appropriate.
- Keywords
- Digital phenotyping, Passive sensing, Wearable electronic devices, Mood episode, Mood episode recurrence, Circadian rhythm, Smartphone sensing, Heart rate, Sleep, Physical activity, Bipolar disorder, Major depressive disorder, Artificial intelligence, Personalized prediction
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Mood Disorders, Motor Activity
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. | |
| Healthy Control | Adults aged 19-75 years with no current or lifetime diagnosis of major depressive disorder, bipolar I disorder, or bipolar II disorder, a baseline PHQ-9 score <5, and no past or current persistent mood symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve (AUROC) for Prediction of Clinician-Adjudicated Depressive Episode Onset
The predictive performance of the digital phenotype-based model developed using the preceding MentalHERO cohort will be evaluated in the present independent prospective cohort. Clinician-adjudicated depressive episode onset during follow-up will be used as the reference outcome. Model discrimination will be assessed using the area under the receiver operating characteristic curve (AUROC), with higher values indicating better discrimination.
Measured: From baseline through Month 12
Secondary outcomes (6)
Area Under the Precision-Recall Curve (AUPRC) for Prediction of Clinician-Adjudicated Depressive Episode Onset
Model performance will be evaluated using the area under the precision-recall curve (AUPRC), which summarizes the trade-off between precision and recall for prediction of clinician-adjudicated depressive episode onset. Higher values indicate better predictive performance.
Measured: From baseline through Month 12
Sensitivity for Prediction of Clinician-Adjudicated Depressive Episode Onset
Sensitivity will be calculated as the proportion of depressive episode onsets correctly identified by the prediction model using the prespecified model decision threshold.
Measured: From baseline through Month 12
Specificity for Prediction of Clinician-Adjudicated Depressive Episode Onset
Specificity will be calculated as the proportion of non-episode observations correctly classified by the prediction model using the prespecified model decision threshold.
Measured: From baseline through Month 12
Accuracy for Prediction of Clinician-Adjudicated Depressive Episode Onset
Overall classification accuracy of the prediction model will be evaluated against clinician-adjudicated depressive episode status.
Measured: From baseline through Month 12
Time-Dependent AUC for Early Prediction of Depressive Episode Onset
The ability of the digital phenotype-based prediction model to identify impending depressive episode onset 3-7 days in advance will be assessed using time-dependent area under the curve (AUC).
Measured: From baseline through Month 12
Occurrence of Clinician-Adjudicated Depressive Episodes
The occurrence and day-level onset and offset of depressive episodes during follow-up will be determined through structured inter-visit mood-episode assessment and clinician adjudication using available clinical information and daily mood records.
Measured: From baseline through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start13 May 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
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
- NCT07880015
- Sponsor's protocol ID
- MY MENTAL HERO_Validation
- Other IDs
- RS-2024-00469788
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No