Understanding anxiety, depression, and bipolar disorder over time in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective cohort study collects clinical, biological, imaging, EEG, wearable, and digital data from participants with anxiety disorders, depressive disorders, bipolar disorder, and healthy controls. It aims to build a standardized research database and develop models that relate symptoms with biomarkers and digital measurements. The study uses longitudinal assessments at baseline and multiple follow-ups over 36 months, plus multi-omics and neuroimaging analyses to explore disease trajectories and prediction across centers. Enrollment is in two cohorts (development and independent validation) totaling approximately 2,690 participants, with careful data integration across sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Ming Zheng, PhD
• Email: mingzheng17@hotmail.com
• Phone: +8619550211701

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.