Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia

Обзор

Schizophrenia is a severe mental illness that seriously affects the health and functioning of patients. Previous studies have found immunoinflammatory abnormalities in the blood, cerebrospinal fluid, central nervous system, and neuroimaging of people with schizophrenia, along with therapeutic effects of anti-inflammatory drugs on schizophrenia. These evidences suggest a close relationship between schizophrenia and immunity and inflammation. Therefore, we consider that the state of immune inflammation is a potential subtype classification basis for schizophrenia, and hypothesize that immune classification based on peripheral-central multidimensional data is related to patient's response to medication and cognition.

Подробное описание

This is a single-center prospective cohort study with longitudinal follow-up of patients with schizophrenia and cross-sectional data from healthy controls matched for sex and age. Participants who meet the inclusion and exclusion criteria will receive a 3-month follow-up with clinical information, biological samples, and imaging data collected at baseline, 1st and 3rd months. The aim of this project is to analyze peripheral-central immune-inflammatory performance and changes in patients with different clinical subtypes of schizophrenia through the use of scale assessments, biospecimen analysis, and imaging data. The Positive and Negative Symptom Scale (PANSS) is used to evaluate the patient's clinical status; MATRICS Consensus Cognitive Battery (MCCB) is used to assess cognition; biological samples such as blood and cerebrospinal fluid are used for multi-omics including immunohistology, inflammation-related molecules, single-cell sequencing, and extracellular vesicles; multi-modal imaging scans are used to react to the brain's structure, function, water molecule diffusion properties, and magnetization; EEG is used to react to the electrophysiological situation.

Вмешательства

• Другое Regular follow-up assessments without intervention.
  Participants will receive a 3-month follow-up with clinical information, biological samples, and imaging data collected at baseline, 1st and 3rd months. The baseline assessment will include demographic information, medical history and previous medication use. At baseline and follow-up, patients' physical examination data (height, weight, waist and hip circumference, etc.), clinical symptom assessment scales (PANSS, SANS, SAPS, CDSS, CPSS, CGI, GAF, PSP, and SAS) and MCCB cognitive assessment dat
• Другое Cross-sectional assessment
  Volunteers' physical examination data (height, weight, waist circumference, hip circumference, etc.), scale assessments (SCID, SCL-90, and CPSS) and MCCB cognitive assessment data, blood samples, MRI, and EEG data will be collected. Blood was collected and stored for exploring differences between patients and healthy individuals.

Первичные конечные точки

• Change of clinical symptoms by PANSS [Срок оценки: baseline, 1st month, 3rd month]
• Change of the MCCB score [Срок оценки: baseline, 1st month, 3rd month]
• Changes of MRI [Срок оценки: baseline, 1st month, 3rd month]
• Changes of peripheral and central inflammatory factors [Срок оценки: baseline, 1st month, 3rd month]
• Changes of autoantibody [Срок оценки: baseline, 1st month, 3rd month]
• Changes of peripheral immune cells [Срок оценки: baseline, 1st month, 3rd month]
• EEG physiological detection index [Срок оценки: baseline, 1st month, 3rd month]

Вторичные конечные точки (9)

• Changes of other biological indicators [Срок оценки: baseline, 1st month, 3rd month]
• Change of clinical symptoms by Clinical Global Impression [Срок оценки: baseline, 1st month, 3rd month]
• Change of social function by Personal and Social Performance Scale [Срок оценки: baseline, 1st month, 3rd month]
• Change of Body Mass Index [Срок оценки: baseline, 1st month, 3rd month]
• Change of the level of blood lipids [Срок оценки: baseline, 1st month, 3rd month]
• Change of waist-hip circumference [Срок оценки: baseline, 1st month, 3rd month]
• Changes of the level of fasting blood glucose [Срок оценки: baseline, 1st month, 3rd month]
• Changes of Scale for Assessment of Positive Symptoms [Срок оценки: baseline, 1st month, 3rd month]
• Changes of Scale for Assessment of Negative Symptoms [Срок оценки: baseline, 1st month, 3rd month]

Критерии участия

Критерии включения

• Clinical diagnosis that meets ICD-11 criteria for schizophrenia.
• Confirmation of the diagnosis of schizophrenia using the SCID-5-RV.

Критерии исключения

• Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).
• Presence of severe or acute physical illnesses, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute cardiovascular diseases, acute respiratory system diseases, acute hematological disorders, autoimmune disease, etc.
• Presence of clearly defined genetic diseases, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47, XXY), etc.

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

• Department of Psychiatry, the Second Xiangya Hospital of Central South University — Чанша

Идентификаторы

NCT: NCT06673966 · Immune inflammation

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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