COMT Genotype and Response to Cognitive Remediation in Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- To evaluate the effect of the association of COMT Val108/158 Met genotype with the response to a computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.
研究概览
简要总结
This project will explore the relationship between catechol-O-methyltransferase (COMT) Val158/108Met genotype and response to a 12-week computerized neurocognitive rehabilitation (CRT) given to chronic schizophrenic patients.
详细描述
Cognitive deficits play a crucial role in both the pathogenesis and prognosis of schizophrenia. The COMT gene is functionally expressed in neural systems considered important in a range of healthy brain functions and brain disorders, including schizophrenia. The COMT Met allele has been shown to be associated with a lower activity form of COMT, and with better performance on neurocognitive tests, while the COMT Val allele is associated with poorer executive cognition. This study will investigate the relationship of COMT polymorphism in patients with chronic schizophrenia with the response to CRT targeting visuospatial processing, attention, and cognitive flexibility using MATRICS Consensus Cognitive Battery (MCCB) developed by the NIH-MATRICS initiative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the active arm of the neurocognitive remediation program
- •Age 18 - 55
- •DSM-IV diagnosis of schizophrenia (all subtypes) with illness duration >5 years
- •Auditory and visual acuity adequate to complete cognitive tests
- •Stable dose of oral atypical antipsychotic for at least 4 weeks
- •Total PANSS score > 60
- •RBANS total score ≤ 80
- •MMSE score of greater than or equal to 24
- •Good physical health determined by physical examination, laboratory tests
- •Capacity and willingness to give written informed consent
排除标准
- •Inability to read or speak English
- •Documented disease of the central nervous system
- •History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
- •Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions
- •Patients diagnosed with substance dependence
- •Currently participating in another experimental study, except for the parent study.
结局指标
主要结局
To evaluate the effect of the association of COMT Val108/158 Met genotype with the response to a computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.
时间窗: 12 weeks
次要结局
- To expand the response to a computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia to other haplotypes or identified genes.(12 weeks)
- To assess the differences between antipsychotic treatment and response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.(12 weeks)
- To assess the differences in demographic variables (e.g. ethnicity, intellectual functioning as measured by WRAT III Reading test, and age) with response to computerized neurocognitive rehabilitation treatment in patients with chronic schizophrenia.(12 weeks)
研究者
Jean-Pierre Lindenmayer
Clinical Director
Manhattan Psychiatric Center