NCT07880015Csak meghívásos
Digital Phenotypes for Predicting Depression_Validation
Discovery and Validation of Digital Phenotypes for Predicting Recurrence of Depressive Episodes_Validation Set Collection
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 27.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Csak meghívásos
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 200 (tervezett)
- Első benyújtás
- 2026. okt. 11.
- Kezdés
- 2026. máj. 13.
- Elsődleges befejezés
- 2027. okt. 30.
- Fő szponzor
- Korea University Anam Hospital
- Betegségek
- Depresszió, Bipoláris zavar
- NCT-szám
- NCT07880015
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 200
- 2026. máj. 13. és az elsődleges befejezés (2027. okt. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Has experienced symptoms suggestive of depression or bipolar disorder in the past but has never received a psychiatric diagnosis for these symptoms.
Más betegség
- 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.
Egyéb
- 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.
A regiszterben nem jelölt feltételek
- 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.
Életkor a regiszterben: 19 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Korea University Anam Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.