Second Affiliated Hospital, School of Medicine, Zhejiang
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
NCT Number: NCT07479758
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.
Interested in participating?
Request Info18 year–45 year
Female
Observational
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and 4 weeks post-treatment
Concentration of GABA in the middle temporal visual cortex complex (MT+) and primary visual cortex (V1) measured via 7T magnetic resonance spectroscopy (MRS).Unit of Measure: Millimolar (mM)
Time frame: Baseline and 4 weeks post-treatment
Concentration of Glu in the middle temporal visual cortex complex (MT+) and primary visual cortex (V1) measured via 7T magnetic resonance spectroscopy (MRS).Unit of Measure: Millimolar (mM)
Time frame: Baseline and 4 weeks post-treatment
Clinical symptom severity as measured by the Hamilton Depression Rating Scale (HAMD).Unit of Measure: Total score on HAMD scale (Range 0-52, higher scores indicate greater severity).
Time frame: Baseline and 4 weeks post-treatment
Clinical symptom severity as measured by the Positive and Negative Syndrome Scale (PANSS). Unit of Measure: Total score on PANSS scale (Range 30-210, higher scores indicate greater severity).
Time frame: Baseline and 4 weeks post-treatment
Clinical symptom severity as measured by the Young Mania Rating Scale (YMRS).Unit of Measure: Total score on YMRS scale (Range 0-60, higher scores indicate greater severity).
Time frame: Baseline and 4 weeks post-treatment
Performance in visual motion perception assessed using standardized psychophysical experiments.Unit of Measure: Degrees per second (°/s) or threshold values
Time frame: Baseline and 4 weeks post-treatment
Perceptual switching rate during binocular rivalry task assessed via psychophysical experiments.Unit of Measure: Number of switches per minute
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
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