An observational study in Major Depressive Disorder, Bipolar I Disorder and Bipolar II Disorder, sponsored by Korea University Anam Hospital. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Korea University Anam Hospital · Observational
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.
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.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's planned enrollment of 200 is above the median of 135 across 365 observational studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Korea University Anam Hospital is the lead sponsor of 111 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Patient group
Healthy control group
Exclusion Criteria Patient group
Healthy control 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.
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.
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.
Time frame: From baseline through Month 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: From baseline through Month 12
Longitudinal Depressive Symptom Severity Measured by the Patient Health Questionnaire-9 (PHQ-9)
Depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. Longitudinal changes across scheduled study visits will be examined.
Time frame: Baseline and Months 3, 6, 9, and 12
Longitudinal Depressive Symptom Severity Measured by the Korean Montgomery-Åsberg Depression Rating Scale (K-MADRS)
Clinician-rated depressive symptom severity will be assessed using the K-MADRS in the patient group, with higher scores indicating greater depressive symptom severity.
Time frame: Baseline and Months 3, 6, 9, and 12
Longitudinal Manic Symptom Severity Measured by the Young Mania Rating Scale (YMRS)
Clinician-rated manic symptom severity will be assessed using the Young Mania Rating Scale (YMRS) in the patient group, with higher scores indicating greater manic symptom severity.
Time frame: Baseline and Months 3, 6, 9, and 12
Associations Between Passive Digital Phenotypes and Depressive Episode Status
Longitudinal wearable- and smartphone-derived digital phenotypes, including sleep, physical activity, heart rate, heart-rate variability, circadian rhythm, mobility, ambient light exposure, and smartphone-use features, will be examined for associations with clinician-adjudicated depressive episode status and episode onset.
Time frame: From baseline through Month 12
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Korea University Anam Hospital →