Epigenetic Regulation of Brain-Derived Neurotrophic Factor (BDNF) Gene Expression According to Response to Cognitive Remediation in Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in methylation at Cytosine-phosphate-Guanine (CpG) exon
研究概览
简要总结
This study is a randomised and controlled trial that aims to investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene in patients with Schizophrenia.
详细描述
OBJECTIVES: To investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene. It also aims to test whether BDNF valine-66-methionine (Val66Met) polymorphism influences CRT treatment outcome among people with schizophrenia.
SAMPLE AND METHODS: A randomized and controlled study will be carried out with two groups: patients receiving CRT and patients in control condition without any cognitive intervention and receiving Treatment as Usual (TAU). Methylation levels of BDNF gene at different sites will be contrasted before and after treatment. Additionally, neurocognition profile, level of symptoms and psychosocial functioning will also be tested. CRT outcomes will be investigated in a mixed model for repeated measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia according to DSM-5 and confirmed by the semi-structured interview (SCID) for the axis
- •Presence of cognitive impairment confirmed by the neuropsychological battery
- •Stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment .
排除标准
- •Presence of organic-cerebral affectation due to neurological or traumatic conditions
- •Antipsychotic dose change >10%
- •Abuse of psychotropic substances
- •Presence of other psychiatric symptomatology
结局指标
主要结局
Change in methylation at Cytosine-phosphate-Guanine (CpG) exon
时间窗: Baseline and after 4 months
Mean methylation percentage in CpG island BDNF CpG exon I: located at chr11:27743473-27744564 in the BDNF
Change in methylation at CpG exon IV
时间窗: Baseline and after 4 months
Mean methylation percentage of CpG region BDNF CpG exon IV: located at chr11:27723060-27723294 in exon IV, upstream of the start codon in exon VII
次要结局
- Change in cognition(Baseline and after 4 months)
- Change in Symptoms(Baseline and after 4 months)
研究者
Rafael Penades
Principal Investigator
Hospital Clinic of Barcelona