Not_yet_recruitingNCT07604129

Development and Validation of an Early Prediction Model for Schizophrenia Integrating Transcranial Sonography Structural Imaging and Machine Learning

Sponsor: Taizhou Second People's Hospital

Trial Details

ConditionSchizophrenia
InterventionTranscranial Sonography
StatusNot_yet_recruiting
Participants200
Est. Completion31 Dec 2027
Last Updated22 May 2026

Primary Outcome

Area Under the ROC Curve of the Final TCS-Clinical Model

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: Schizophrenia group: 1. Adults aged 18 to 65 years. 2. Diagnosis of schizophrenia according to ICD-10 criteria by a psychiatrist. 3. Able to complete clinical assessment and transcranial sonography examination. 4. No other severe physical disease, neurological disease, or major psychiatric disorder. 5. Written informed consent provided by the participant or legally authorized representative. Healthy control group: 1. Adults aged 18 to 65 years. 2. No personal history of psychiatric disorders. 3. No family history of psychiatric disorders. 4. No severe physical disease, neurological disease, or major psychiatric disorder. 5. Basic demographic characteristics matched as far as possible to the schizophrenia group. 6. Able to complete clinical assessment and transcranial sonography examination. 7. Written informed consent provided by the participant or legally authorized representative. Exclusion Criteria: 1. Severe physical disease or neurological disease. 2. History of drug or alcohol abuse. 3. Inability to complete clinical assessment or transcranial sonography examination. 4. Inadequate temporal acoustic window or poor image quality preventing valid transcranial sonography measurements. 5. Acute or clinically unstable state that prevents completion of study procedures. 6. Comorbid major psychiatric disorder, such as major depressive disorder. 7. Refusal or withdrawal of informed consent.

Trial Sites

Countries

China
View Registry Entry

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