Biomarkers in First Episode Schizophrenia
Từ khóa
trừu tượng
Sự miêu tả
It is currently unknown whether deterioration early in the course of psychotic illness represents medication toxicity or the natural course of the illness. The study will help clarify this issue in observing 20 schizophrenic patients before and after they are prescribed an antipsychotic via standard of care.
In addition, schizophrenia is a heterogeneous disorder and a putative brain-derived neurotrophic factor (BDNF) deficit, while possibly a common pathway, may not fully capture the biological diversity-the supplemental biomarkers will allow us to perform a more comprehensive assessment of factors contributing to clinical course. Taken together analysis of these biomarkers in relation to clinical course and in relation to healthy subjects will inform us about biological mechanisms contributing to illness onset, effects of antipsychotic medication on these mechanisms, and the predictive value of the biomarkers for clinical course. This information will provide the foundation for future early intervention trials targeting biological mechanisms utilizing a personalized medicine approach.
The baseline visit for 20 schizophrenic patients and 20 healthy age and gender matched controls consists of structural and functional MRI in addition to a blood draw for biomarkers including BDNF, inflammation markers, DNA, oxidative stress, and folate status and additionally a salivary cortisol sample collection. Biomarkers and imaging will be repeated after 8 weeks of antipsychotic treatment in patients.
ngày
| Xác minh lần cuối: | 06/30/2017 |
| Đệ trình đầu tiên: | 01/06/2014 |
| Đăng ký ước tính đã được gửi: | 01/08/2014 |
| Đăng lần đầu: | 01/09/2014 |
| Cập nhật lần cuối được gửi: | 07/11/2017 |
| Cập nhật lần cuối đã đăng: | 07/12/2017 |
| Ngày bắt đầu nghiên cứu thực tế: | 06/30/2012 |
| Ngày hoàn thành chính ước tính: | 06/30/2017 |
| Ngày hoàn thành nghiên cứu ước tính: | 05/31/2018 |
Tình trạng hoặc bệnh tật
Giai đoạn
Nhóm cánh tay
| Cánh tay | Can thiệp / điều trị |
|---|---|
| Healthy Controls Age and gender matched healthy controls | |
| Patients Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment. |
Đủ tiêu chuẩn
| Tuổi đủ điều kiện để học | 16 Years Đến 16 Years |
| Giới tính đủ điều kiện để nghiên cứu | All |
| Phương pháp lấy mẫu | Non-Probability Sample |
| Chấp nhận tình nguyện viên lành mạnh | Đúng |
| Tiêu chí | Inclusion Criteria: 1. Male or female 2. Ages 15-40 years 3. Schizophrenia, any subtype or Schizophreniform disorder 4. Sufficient proficiency in English or Spanish to complete assessments (US) Exclusion Criteria: 1. Major depression by the Diagnostic and Statistical Manual of Mental Disorders IV criteria 2. Calgary Depression Scale for Schizophrenia (CDSS) score of 7 or greater. 3. Clinical Global Assessment of Severity of Suicidality of 3 (moderate) or greater. 4. Serious suicide attempt within three years 5. Treatment with an antipsychotic or antidepressant within the last six months 6. Active alcohol or other substance abuse or dependence within one month 7. Unstable medical illness |
Kết quả
Các biện pháp kết quả chính
1. Biomarkers [Baseline]
2. Change in Biomarkers [Baseline, week 4, week 8]
Các biện pháp kết quả thứ cấp
1. Grey Matter [Baseline]
2. Cognitive Performance [Baseline, week 8]
3. Change in Grey Matter [Baseline, week 8]
