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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07479758
Enrollment
320
Registered
2026-03-18
Start date
2025-11-01
Completion date
2027-06-30
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Major Depressive Disorder (MDD), Schizophrenia, Severe Mental Disorders

Keywords

Ultra-High-Field MRI, Visual Perception, Magnetic Resonance Spectroscopy, Mental Health Biomarkers

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Concentration of gamma-aminobutyric acid (GABA) in visual cortexBaseline and 4 weeks post-treatmentConcentration 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 cortexBaseline and 4 weeks post-treatmentConcentration 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)

Secondary

MeasureTime frameDescription
Severity of depressive symptoms in MDD patientsBaseline and 4 weeks post-treatmentClinical 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).
Severity of psychotic symptoms in SZ patientsBaseline and 4 weeks post-treatmentClinical 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).
Severity of manic symptoms in BD patientsBaseline and 4 weeks post-treatmentClinical 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).
Visual motion perception speedBaseline and 4 weeks post-treatmentPerformance in visual motion perception assessed using standardized psychophysical experiments.Unit of Measure: Degrees per second (°/s) or threshold values
Binocular rivalry perceptual switching rateBaseline and 4 weeks post-treatmentPerceptual switching rate during binocular rivalry task assessed via psychophysical experiments.Unit of Measure: Number of switches per minute

Countries

China

Contacts

CONTACTZheng Lin
Linzzr@126.com86-13757118261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026