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Идёт набор NCT07479758

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

— Наблюдательное Major Depressive Disorder (MDD) Schizophrenia Bipolar Disorder Severe Mental Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Major Depressive Disorder (MDD), Schizophrenia, Bipolar Disorder, Severe Mental Disorders. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Первичные конечные точки

  • Concentration of gamma-aminobutyric acid (GABA) in visual cortex [Срок оценки: Baseline and 4 weeks post-treatment]
  • Concentration of glutamate (Glu) in visual cortex [Срок оценки: Baseline and 4 weeks post-treatment]
Вторичные конечные точки (5)
  • Severity of depressive symptoms in MDD patients [Срок оценки: Baseline and 4 weeks post-treatment]
  • Severity of psychotic symptoms in SZ patients [Срок оценки: Baseline and 4 weeks post-treatment]
  • Severity of manic symptoms in BD patients [Срок оценки: Baseline and 4 weeks post-treatment]
  • Visual motion perception speed [Срок оценки: Baseline and 4 weeks post-treatment]
  • Binocular rivalry perceptual switching rate [Срок оценки: Baseline and 4 weeks post-treatment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Second Affiliated Hospital, School of Medicine, Zhejiang — Ханчжоу

Идентификаторы

NCT: NCT07479758 · 2025-11-20

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗