Creating a clinical database and biobank for schizophrenia
Establishing a Clinical Database and Biobank for Schizophrenia：A Cohort Study
Central South University · NCT06123897
This study is creating a large database and biobank to collect information and blood samples from people with schizophrenia to better understand the condition and find new ways to diagnose and treat it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Central South University (other) |
| Locations | 4 sites (Hefei, Anhui and 3 other locations) |
| Trial ID | NCT06123897 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to establish a comprehensive cohort of patients with schizophrenia across various age groups and disease stages. Participants will undergo standardized diagnostic assessments and regular follow-ups for at least one year, during which extensive clinical data will be collected. The study will utilize a multidimensional assessment framework to investigate the etiology, disease progression, and clinical outcomes of schizophrenia. Additionally, blood samples will be collected for biomarker exploration, contributing to early diagnosis and improved treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals clinically diagnosed with schizophrenia according to ICD-11 criteria.
Not a fit: Patients with neurodevelopmental disorders, bipolar disorders, substance use disorders, or severe physical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better early diagnosis and treatment options for patients with schizophrenia.
How similar studies have performed: Other studies have successfully established similar clinical databases and biobanks, indicating the potential for this approach to yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Clinical diagnosis of schizophrenia according to ICD-11. * 2.Confirmation of the diagnosis of schizophrenia using the SCID-5-RV (DSM-5 Structured Clinical Interview for DSM-5 Disorders - Research Version). 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, 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
Hefei, Anhui and 3 other locations
- Anhui Mental Health Center — Hefei, Anhui, China (ACTIVE_NOT_RECRUITING)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (ACTIVE_NOT_RECRUITING)
- Mental Health Institute of Second Xiangya Hospital,CSU — Changsha, Hunan, China (RECRUITING)
- Nanjing Brain Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (ACTIVE_NOT_RECRUITING)
Study contacts
- Study coordinator: Renrong Wu, M.D., Ph.D.
- Email: wurenrong2013@163.com
- Phone: 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.
Conditions: Schizophrenia, Schizophrenia, Cohort Study