Clinical Trials in China / NCT07903246
Recruiting
Observational
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
NCT07903246 · tracked via the Priya Life Science China tracker
Condition(s) studied
Anxiety DisordersDepressive DisorderBipolar Disorder (BD)
Study 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.
Eligibility
Inclusion Criteria:
General criteria for all groups:
* Age 12 to 55 years, inclusive, of any sex.
* Education at or above the third-grade primary school level.
* Voluntary participation with written informed consent. For participants younger than 18 years, written informed consent from a legal guardian and the participant's assent, when capable, are required. For participants with impaired consent capacity, consent will be obtained from the participant and/or legal guardian as specified in the protocol.
Anxiety disorders group:
* Meet DSM-5 diagnostic criteria for one or more anxiety spectrum disorders.
* Hamilton Anxiety Rating Scale (HAMA-14) total score of at least 14.
* Normal intellectual functioning, vision, and hearing.
Depressive disorders group:
* Meet DSM-5 diagnostic criteria for one or more depressive disorders.
* Hamilton Depression Rating Scale (HAMD-17) total score of at least 17.
* Normal intellectual functioning, vision, and hearing.
Bipolar disorder group:
* Meet DSM-5 diagnostic criteria for bipolar I or bipolar II disorder.
* Not currently experiencing a manic episode.
* Normal intellectual functioning, vision, and hearing.
Healthy control group:
* Normal or corrected-to-normal vision.
* Good physical health, without serious physical illness or chronic disease.
* Normal cognitive functioning.
* No family history of mental illness across three generations on either the maternal or paternal side.
Exclusion Criteria:
* The following criteria apply to all groups:
* Failure to meet the inclusion criteria for the relevant group, or meeting DSM-5 criteria for a mental disorder other than those targeted by this study.
* Current risk of dangerous behavior, rated as level 2 or above on the dangerousness assessment specified in the protocol.
* Severe agitation, oppositional behavior, or markedly reduced volition or activity that prevents completion of the assessments.
* Current or previous organic brain disease, a history of epilepsy, or a history of traumatic brain injury.
* A history of drug or substance abuse, including tobacco, alcohol, or other psychoactive substances.
* Cardiovascular, cerebrovascular, respiratory, or neurological disease; infectious disease; other serious physical illness; or a pathological condition that may cause cognitive impairment.
* Limb disability or inability to make the required button-press responses using the upper limbs.
* Pregnancy or breastfeeding.
* Electroconvulsive therapy, transcranial magnetic stimulation, alternating-current or direct-current electrical stimulation, vagus nerve stimulation, or deep brain stimulation within the previous 6 months.
* Metal implants or other metallic objects that cannot be safely removed and prevent safe magnetic resonance imaging.
* Red-green color blindness.
* Any other condition that, in the investigator's judgment, makes participation unsuitable.
Primary outcome measure(s)
- 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).
The model will use multimodal digital phenotyping data to identify three diagnostic labels: depressive disorders, anxiety disorders, and bipolar disorder. Reference diagnoses will be established by psychiatrists using MINI interviews and clinical diagnostic assessment. Co-occurring diagnoses will be represented according to diagnostic criteria, allowing anxiety disorders to coexist with depressive or bipolar disorders. An area under the receiver operating characteristic curve (AUC) will be calculated separately for each label. The primary measure will be the unweighted mean of the three label-specific AUCs. Healthy controls will be negative for all three labels. AUC ranges from 0 to 1, with higher values indicating better discrimination. A 95% confidence interval will be calculated using bootstrap resampling. Feature selection, tuning, and training will be completed in the development cohort, and the model will be locked before independent validation. - 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.
Depressive symptom severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17). Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Results will be analyzed separately for the depressive disorders group and the bipolar disorder group. Negative changes indicate improvement. - 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.
Anxiety symptom severity will be assessed using the 14-item Hamilton Anxiety Rating Scale (HAMA-14). Each item is scored from 0 to 4, yielding a total score from 0 to 56. Higher scores indicate more severe anxiety symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Negative changes indicate improvement. - 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.
Manic symptom severity in participants with bipolar disorder will be assessed using the 11-item Bech-Rafaelsen Mania Rating Scale (BRMS). Each item is scored from 0 to 4, yielding a total score from 0 to 44. Higher scores indicate more severe manic symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Negative changes indicate improvement.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07903246 on ClinicalTrials.gov ↗ ← All trials in China