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Life sciences · Observational Study
ClinicalTrials.gov · October 29, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07903246). This is a study registration, not published results. Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 2690 participants (ESTIMATED). Conditions: Anxiety Disorders, Depressive Disorder, Bipolar Disorder (BD). Primary outcome measures: Macro-Averaged Area Under the ROC Curve of the Multimodal Digital Phenotyping-Based Diagnostic Model in the Independent Validation Cohort , Baseline (at enrollment in the independent validation cohort).; Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Score , Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.; Change From Baseline in 14-Item Hamilton Anxiety Rating Scale (HAMA-14) Score , Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.; Change From Baseline in Bech-Rafaelsen Mania Rating Scale (BRMS) Score in the Bipolar Disorder Group , Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.. Brief summary: This study aims to understand how anxiety disorders, depressive disorders, and bipolar disorder change over time and to identify patterns that may help with earlier recognition, diagnosis, and prediction of future symptoms. The study will enroll approximately 2,690 participants aged 12 to 55 years across multiple hospitals in China. Participants will include people with anxiety disorders, depressive disorders, or bipolar disorder, as well as healthy volunteers for comparison. Participants will be followed for 3 years after enrollment, with assessments at baseline and at 1, 6, 12, 18, 24, 30, and 36 months. Study assessments will collect information about symptoms, treatment, daily functioning, and quality of life. Other study data will include biological samples, brain imaging, recordings of brain electrical activity, and measurements from wearable devices and tasks involving speech, facial expressions, and eye movements. Researchers will examine how these measurements relate to symptoms and changes in health over time. They will also develop and evaluate artificial intelligence models intended to help identify these disorders and predict treatment outcomes, relapse, and suicide or self-harm risk. This is an observational study. The researchers will not assign treatments or change participants' treatment as part of the study. Treatments received during routine clinical care will be recorded.