Epigenetic Regulation of BDNF and TrK B in Schizophrenic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- BDNF and Trk B DNA methylation, protein and mRNA levels
研究概览
简要总结
In this proposal, we will (1) detect the associations between BDNF and Trk B gene DNA methylation, histone modification, psychotic symptoms, obesity, suicide and antipsychotic drug responses in Taiwanese patients (2) discuss the possible mechanisms of epigenetic regulation of BDNF and Trk B in schizophrenia patients.
详细描述
A total 160 subjects (80 subjects every year, including 40 healthy controls and 40 schizophrenia patients) will be recruited during a 2-year period. The first year, the baseline data of BDNF and Trk B DNA methylation, protein and mRNA levels in all subjects will be collected and the following 1 months data will also be collected in schizophrenia with antipsychotic drug treatments. The second year, the baseline data of BDNF and Trk B histone modification in all subjects will be collected.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The clinical screening and assessment in schizophrenic patients：
- •40 schizophrenia patients will be recruited in psychiatric inpatients according to DSM-IV criteria (APA, 1994) by a structured interview (SCID). The assessment will be done by two senior psychiatrists. The intra-rater and inter-rater reliability will be done before this project started
- •age : 18-65 years old.
- •The patients had the ability to complete the written inform consent.。
- •The choice of antipsychotic drugs depended on the need of patients in natural treatment procedure. They included conventional drugs, eg.haloperidol 10-20 mg/day；SDA (serotonin dopamine antagonist) drug, eg. clozapine 100-400 mg/day or risperidone 3-6mg/day. The choice of the medication was according to the need of patients including previous responses and side effects.
- •PANSS (Positive and Negative Syndrome)(Kay, 1987,1988&1989) for positive, negative symptoms and severity.
- •Check body mass index (BMI): if BMI<24: normal; 24<BMI<27: overweight; BMI>27: obesity (Taiwan criteria, 2004). If the patients were overweight or obesity, the lipid profiles would be done and we would consult the experts to assess these patients. The condition for diet control and daily activity will be observed. If the condition was extremely abnormal, the case will be excluded.
- •Suicide behavior in tis study includes complete suicide and suicide attempt.
排除标准
- •The patients had systemic diseases, including metabolic, heart, and liver diseases。
- •The patients had received any drugs before entering this protocol.
- •The patients were heavy smokers or dependent on alcohol.
结局指标
主要结局
BDNF and Trk B DNA methylation, protein and mRNA levels
时间窗: Two years
次要结局
- the associations between BDNF and Trk B gene DNA methylation, histone modification, psychotic symptoms, obesity, suicide and antipsychotic drug responses in Taiwanese patients(two years)
研究者
Tiao-Lai Huang
Head of Department of Psychiatry
Chang Gung Memorial Hospital