NCT07880015Enrolling by invitation
Digital Phenotypes for Predicting Depression_Validation
Discovery and Validation of Digital Phenotypes for Predicting Recurrence of Depressive Episodes_Validation Set Collection
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 11 Oct 2026
- Start date
- 13 May 2026
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Korea University Anam Hospital
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT07880015
What you commit to
- Study type: Observational
- Planned participants: 200
- From 13 May 2026 to the primary completion date, 30 Oct 2027
- 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.
Prior treatment
- Has experienced symptoms suggestive of depression or bipolar disorder in the past but has never received a psychiatric diagnosis for these symptoms.
Other illness
- 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 a history of psychiatric consultation or treatment, including for psychiatric conditions other than major depressive disorder or bipolar disorder.
- 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.
Other
- 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.
- 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 baseline PHQ-9 score ≥5.
- 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.
Criteria the registry did not label
- Patient group
- Adults aged 19-75 years.
- Meets DSM-5 diagnostic criteria for major depressive disorder, bipolar I disorder, or bipolar II disorder, and has a history of visiting a psychiatric clinic for symptoms related to the disorder.
- Has experienced at least one major depressive episode in the past.
- Owns and is able to use an internet-connected smartphone and agrees to wear the study-provided wearable device daily throughout the study period and to complete daily mood recordings through the digital phenotyping application.
- Healthy control group
- Adults aged 19-75 years.
- Has no current or past diagnosis of major depressive disorder, bipolar I disorder, or bipolar II disorder.
- Has a baseline Patient Health Questionnaire-9 (PHQ-9) score \<5.
- Owns and is able to use an internet-connected smartphone and agrees to wear the study-provided wearable device daily throughout the study period and to complete daily mood recordings through the digital phenotyping application.
Age in the registry: 19 years to 75 years · Sex: All · Accepts healthy volunteers
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.