Detecting immune inflammation and brain changes in schizophrenia
Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia
This study looks at how inflammation in the immune system might be linked to schizophrenia by comparing patients with the condition to healthy individuals over three months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06673966 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between immune-inflammatory states and schizophrenia by analyzing clinical, biological, and imaging data. It involves a cohort of patients diagnosed with schizophrenia who will be followed for three months, during which various assessments will be conducted, including clinical evaluations and biological sample collection. The study also includes a control group of healthy individuals matched for age and sex to provide comparative data. The goal is to identify potential subtypes of schizophrenia based on immune responses and their correlation with treatment outcomes and cognitive function.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with schizophrenia according to ICD-11 criteria.
Not a fit: Patients with neurodevelopmental disorders, bipolar disorder, or severe physical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved classification and treatment strategies for schizophrenia based on immune-inflammatory profiles.
How similar studies have performed: Previous studies have indicated a potential link between immune responses and schizophrenia, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosis that meets ICD-11 criteria for schizophrenia. 2. Confirmation of the diagnosis of schizophrenia using the SCID-5-RV. Exclusion Criteria: 1. Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco). 2. 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. 3. 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.
Where this trial is running
Changsha, Hunan
- Department of Psychiatry, the Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Renrong Wu, M.D., Ph.D.
- Email: wurenrong2013@163.com
- Phone: +86 15874179855
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.