7T MRI and visual perception markers for severe mood and psychotic disorders
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 University · NCT07479758
This project tests whether 7‑tesla MRI scans combined with visual perception tests can identify brain markers linked to diagnosis and treatment outcomes in adults with major depressive disorder, bipolar disorder, or schizophrenia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07479758 on ClinicalTrials.gov |
What this trial studies
This observational project uses ultra‑high‑field (7T) multimodal MRI, including structural, functional, and magnetic resonance spectroscopy, together with standardized visual perception tasks to measure brain changes in people with severe mental disorders. Participants include adults with DSM‑5 diagnoses of major depressive disorder, schizophrenia, or bipolar disorder, plus healthy controls. Imaging and behavioral measures are collected before and after clinical treatment to look for metabolic and connectivity changes that track symptoms and outcomes. The goal is to develop a biomarker system that complements symptom-based diagnosis and helps predict treatment response.
Who should consider this trial
Good fit: Adults aged 18–45 with a DSM‑5 diagnosis of major depressive disorder, schizophrenia, or bipolar disorder who can provide informed consent, have no severe medical or neurological illness, and can safely undergo MRI are ideal candidates.
Not a fit: Patients who cannot have an MRI (metal implants, pacemaker, severe claustrophobia), are pregnant, have major medical or neurological comorbidities, or fall outside the 18–45 age range are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could provide objective brain and visual-processing markers to improve diagnostic precision and help predict which patients will respond to treatment.
How similar studies have performed: Prior work using high‑field MRI and visual‑perception measures has produced promising but inconsistent biomarker signals, and multimodal 7T approaches remain relatively new and not yet clinically validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital, School of Medicine, Zhejiang — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Zheng Lin
- Email: Linzzr@126.com
- Phone: 86-13757118261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, Schizophrenia, Bipolar Disorder, Severe Mental Disorders, Ultra-High-Field MRI, Visual Perception, Magnetic Resonance Spectroscopy, Mental Health Biomarkers