Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Concentration of gamma-aminobutyric acid (GABA) in visual cortex
研究概览
简要总结
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
- Clarify the specific changes in visual perception behavior and brain imaging (metabolism, functional connectivity) of patients with severe mental disorders before and after treatment.
- 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
- 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.
- 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
- 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.
- 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.
- 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
- Provide objective biomarkers for clinical practice to improve the accuracy of diagnosis and the scientificity of treatment effect evaluation for severe mental disorders.
- Reveal the association mechanism between visual cortex-related brain networks and diseases, laying a theoretical foundation for precision diagnosis and treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants aged 18 to 45 years old at the time of enrollment
- •Male or female participants
- •For patients: A diagnosis of major depressive disorder (MDD), schizophrenia (SZ), or bipolar disorder (BD) based on DSM-5 criteria
- •For healthy controls: No history of any mental health disorders
- •No current severe medical illnesses or history of brain injury such as encephalitis
- •Ability to provide written informed consent by the participant or their guardian
排除标准
- •History of head injury or brain diseases such as epilepsy
- •Presence of severe physical illnesses such as tumors or thyroid problems
- •Presence of metal implants in the body like pacemakers or brain devices
- •Fear of enclosed spaces (claustrophobia) or inability to undergo an MRI scan
- •Current pregnancy
研究组 & 干预措施
Healthy Control (HC)
Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for MDD; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments (pre- and post-treatment 7T MRI, behavioral tests).
Major Depressive Disorder (MDD)
Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for MDD; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments (pre- and post-treatment 7T MRI, behavioral tests).
Schizophrenia (SZ)
Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for schizophrenia; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments.
Bipolar Disorder (BD)
Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for bipolar disorder; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments.
结局指标
主要结局
Concentration of gamma-aminobutyric acid (GABA) in visual cortex
时间窗: 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)
Concentration of glutamate (Glu) in visual cortex
时间窗: 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)
次要结局
- Severity of depressive symptoms in MDD patients(Baseline and 4 weeks post-treatment)
- Severity of psychotic symptoms in SZ patients(Baseline and 4 weeks post-treatment)
- Severity of manic symptoms in BD patients(Baseline and 4 weeks post-treatment)
- Visual motion perception speed(Baseline and 4 weeks post-treatment)
- Binocular rivalry perceptual switching rate(Baseline and 4 weeks post-treatment)
