Biomarkers in First Episode Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Salivary Cortisol Levels
研究概览
简要总结
This study will identify and evaluate relevant biomarkers and structural brain imaging for understanding potential biological illness related mechanisms in medication-naïve subjects with early psychosis before and after initiation of antipsychotic medication
详细描述
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 70 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 70 schizophrenic patients and 70 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Ages 15-40 years
- •Schizophrenia, any subtype or Schizophreniform disorder
- •Sufficient proficiency in English or Spanish to complete assessments (US)
排除标准
- •Major depression by the Diagnostic and Statistical Manual of Mental Disorders IV criteria
- •Calgary Depression Scale for Schizophrenia (CDSS) score of 7 or greater.
- •Clinical Global Assessment of Severity of Suicidality of 3 (moderate) or greater.
- •Serious suicide attempt within three years
- •Treatment with an antipsychotic or antidepressant within the last six months
- •Active alcohol or other substance abuse or dependence within one month
- •Unstable medical illness
结局指标
主要结局
Salivary Cortisol Levels
时间窗: Baseline
Compare biomarkers for stress (salivary cortisol) in medication-naïve schizophrenia/schizophreniform subjects and matched healthy controls to identify illness-related factors.
Biomarkers
时间窗: Baseline
Compare biomarkers for inflammation, BDNF, oxidative stress, glucocorticoids and folate/methylation status in medication-naïve schizophrenia/schizophreniform subjects and matched healthy controls to identify illness-related factors.
Change in Salivary Cortisol Levels
时间窗: Baseline and week 8
Compare salivary cortisol at baseline and after 8 weeks of risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects to identify treatment-related factors. Since Blood and Saliva was only collected from First Episode participants (FEP) at week 8 (not from healthy controls) these results only report the baseline and week 8 biomarker levels for FEP participants who completed week 8.
次要结局
- Left Hippocampal Volumetric Integrity (HVI)(Baseline)
- Annualized Change in Left Hippocampal Volume Integrity(Baseline, week 8)
- Cognitive Performance(Baseline, week 8)