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Establishment and Clinical Validation of an Intelligent Diagnosis and Personalized Digital Therapeutic System for Affective Disorders

Establishment and Clinical Validation of an Intelligent Diagnosis and Personalized Digital Therapeutic System for Affective Disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117327
Enrollment
Unknown
Registered
2026-01-22
Start date
2026-01-25
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive disorder, anxiety disorder or bipolar disorder

Interventions

Gold Standard:The Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Index test:Information such as electroencephalogram (EEG), near-infrared (fNIRS), physiological signals of smart beds, video, audio and text

Sponsors

Huzhou Third Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for the corresponding disorders (Major Depressive Disorder, Anxiety Disorder, or Bipolar Disorder) as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 2. Aged 18 to 65 years, regardless of gender; 3. Of Han Chinese ethnicity and right-handed.

Exclusion criteria

Exclusion criteria: 1. History of organic brain diseases or head trauma with loss of consciousness; 2. Any major or unstable cardiovascular, respiratory, neurological (including epilepsy or significant cerebrovascular disease, craniocerebral injury), renal, hepatic, endocrine, or immune system disorders, or a history of anxiety, depression, or related conditions due to organic diseases; or current infections or trauma; 3. Hearing impairment (inability to hear or understand the examiner's speech under normal conversation conditions) or visual impairment; 4. History of psychoactive substance abuse or dependence; 5. Pregnant or lactating women, or those planning pregnancy.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale;

Secondary

MeasureTime frame
Hamilton Anxiety Scale;Beck Scale for Suicide Ideation-Chinese Version;

Countries

China

Contacts

Public ContactShen Zhongxia

Huzhou Third Municipal Hospital

snowszx@sina.com+86 57 22290582

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026