{ "data": { "asOf": "2026-10-30T22:27:22.842Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07880015", "title": "Digital Phenotypes for Predicting Depression_Validation", "scientificTitle": "Discovery and Validation of Digital Phenotypes for Predicting Recurrence of Depressive Episodes_Validation Set Collection", "status": "recruiting", "studyType": "observational", "phase": [], "conditions": [ "Major Depressive Disorder", "Bipolar I Disorder", "Bipolar II Disorder", "Mood Disorders" ], "interventions": [], "sponsor": { "name": "Korea University Anam Hospital", "type": "OTHER" }, "locations": [ { "city": "Seoul", "country": "South Korea", "facility": "Korea University Anam Hospital" } ], "outcomes": { "other": [ "Longitudinal Depressive Symptom Severity Measured by the Patient Health Questionnaire-9 (PHQ-9)", "Longitudinal Depressive Symptom Severity Measured by the Korean Montgomery-Åsberg Depression Rating Scale (K-MADRS)", "Longitudinal Manic Symptom Severity Measured by the Young Mania Rating Scale (YMRS)" ], "primary": [ "Area Under the Receiver Operating Characteristic Curve (AUROC) for Prediction of Clinician-Adjudicated Depressive Episode Onset" ], "secondary": [ "Area Under the Precision-Recall Curve (AUPRC) for Prediction of Clinician-Adjudicated Depressive Episode Onset", "Sensitivity for Prediction of Clinician-Adjudicated Depressive Episode Onset", "Specificity for Prediction of Clinician-Adjudicated Depressive Episode Onset", "Accuracy for Prediction of Clinician-Adjudicated Depressive Episode Onset", "Time-Dependent AUC for Early Prediction of Depressive Episode Onset", "Occurrence of Clinician-Adjudicated Depressive Episodes" ] }, "eligibility": { "sex": "ALL", "criteria": "Patient group\n\n1. Adults aged 19-75 years.\n2. 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.\n3. Has experienced at least one major depressive episode in the past.\n4. 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.\n\nHealthy control group\n\n1. Adults aged 19-75 years.\n2. Has no current or past diagnosis of major depressive disorder, bipolar I disorder, or bipolar II disorder.\n3. Has a baseline Patient Health Questionnaire-9 (PHQ-9) score \\<5.\n4. 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.\n\nExclusion Criteria Patient group\n\n1. Has experienced symptoms suggestive of depression or bipolar disorder in the past but has never received a psychiatric diagnosis for these symptoms.\n2. Has a history of moderate or severe intellectual disability.\n3. 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.\n4. Has difficulty reading or understanding Korean.\n5. Has difficulty using a smartphone to an extent that may interfere with study participation, or does not have continuous internet access through the smartphone.\n6. Is judged by the principal investigator to have difficulty identifying mood episodes or independently evaluating mood-episode symptoms.\n\nHealthy control group\n\n1. 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.\n2. Has a history of psychiatric consultation or treatment, including for psychiatric conditions other than major depressive disorder or bipolar disorder.\n3. Has a baseline PHQ-9 score ≥5.\n4. Has a history of moderate or severe intellectual disability.\n5. 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.\n6. Has difficulty reading or understanding Korean.\n7. Has difficulty using a smartphone to an extent that may interfere with study participation, or does not have continuous internet access through the smartphone.\n8. Is judged by the principal investigator to have difficulty identifying mood episodes or independently evaluating mood-episode symptoms.", "maximumAge": "75 Years", "minimumAge": "19 Years", "healthyVolunteers": true }, "enrollment": { "type": "ESTIMATED", "count": 200 }, "startDate": "2026-05-13", "completionDate": "2027-10-30", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2026-10-19T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07880015" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07880015", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07880015", "sourceUrl": "https://clinicaltrials.gov/study/NCT07880015", "sourceStatus": "ENROLLING_BY_INVITATION", "retrievedAt": "2026-10-28T04:33:21.751Z", "payloadSha256": "e706b461b2a4405e845c6463cbfda663bae94b010e65f02ab320f30c0aa24ab7", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07880015", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07880015", "verifyAt": "https://clinicaltrials.gov/study/NCT07880015", "retrievedAt": "2026-10-28T04:33:21.751Z", "payloadSha256": "e706b461b2a4405e845c6463cbfda663bae94b010e65f02ab320f30c0aa24ab7", "text": "ClinicalTrials.gov, record NCT07880015 (https://clinicaltrials.gov/study/NCT07880015), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07880015, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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