Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07479758
Brief Summary:
This is an observational study aiming to screen biomarkers associated with the diagnosis and treatment outcomes of severe mental disorders (MDD/major depressive disorder, SZ/schizophrenia, BD/bipolar disorder) through 7T ultra-high-field magnetic resonance multimodal imaging and visual perception assessment, thereby optimizing the objectivity and precision of clinical diagnosis and treatment.
I. Core Research Objectives
1. Clarify the specific changes in visual perception behavior and brain imaging (metabolism, functional connectivity) of patients with severe mental disorders before and after treatment.
2. Establish a biomarker system related to disease diagnosis and treatment outcomes to make up for the limitation of current clinical reliance on phenomenological diagnosis.
II. Study Subjects and Inclusion/Exclusion Criteria
1. Recruitment Scope
* Patient group: MDD, SZ, and BD patients diagnosed in the Department of Psychiatry, the Second Affiliated Hospital of Zhejiang University School of Medicine.
* Healthy control group: Healthy individuals without a history of mental illness recruited from the general population.
2. Key Criteria
* Inclusion: Aged 18-45 years; meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria (for the patient group); no organic brain injury or severe physical illness; signing the informed consent form.
* Exclusion: Organic brain diseases; severe physical illnesses (e.g., tumors); internal metal implants (e.g., cardiac pacemakers); claustrophobia or inability to tolerate MR examinations; pregnancy, etc.
III. Core Study Procedures
1. All participants will undergo 2 sessions of 7T MRI scans (including MRS, fMRI, and other multimodal sequences), focusing on the MT+ brain region and V1 brain region respectively, with the scan order randomly balanced.
2. During the interval between the two MRI scans, participants will complete visual psychophysical experiments, cognitive function tests (e.g., BDT test), and clinical symptom collection.
3. The study will not interfere with routine clinical treatment and strictly adheres to the ethical standards of the Second Affiliated Hospital of Zhejiang University School of Medicine (Ethical Approval No.: 2025 Lun Shen Yan Di 0603).
IV. Study Significance
1. Provide objective biomarkers for clinical practice to improve the accuracy of diagnosis and the scientificity of treatment effect evaluation for severe mental disorders.
2. Reveal the association mechanism between visual cortex-related brain networks and diseases, laying a theoretical foundation for precision diagnosis and treatment.
Study:
NCT07479758
Study Brief:
Protocol Section:
NCT07479758