跳至主要内容
临床试验/NCT07479758
NCT07479758招募中不适用

Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2025年11月1日最近更新:
适应症

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

  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.
  1. 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.

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

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)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验