COMPARISON OF COGNITIVE, BEHAVIORAL EFFECTS OF LEVETIRACETAM, CARBAMAZEPINE

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项双盲、随机、两阶段交叉研究，比较了常用抗癫痫药物（AED）左乙拉西坦和卡马西平对正常健康志愿者认知和行为的影响。该研究包括25周内的12次访视。四十五（45）例正常健康受试者将接受左乙拉西坦（2000 mg/天）和卡马西平（调整剂量以获得中等范围抗惊厥药物血液水平（ABL），目标ABL = 8.5 μ g/ml，范围= 6-12 μ g/ml）治疗，各8周。每个AED治疗期之后将是为期4天的逐渐减量和洗脱期，在本月剩余时间停用AED。认知和行为功能测试沿着安全性测试将在治疗前基线、每个随机化AED维持期结束时和最终洗脱期后进行。 具体目标：本研究的总体目的是比较左乙拉西坦与卡马西平治疗8周后对健康成人神经心理功能的影响。我们还计划在健康成人中比较左乙拉西坦与卡马西平的安全性和耐受性。假设：我们的假设是，卡马西平的认知影响将大于左乙拉西坦。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a double-blind, randomized, two period crossover study comparing the cognitive and behavioral effects of the commonly-prescribed antiepileptic drugs (AEDs) levetiracetam and carbamazepine in normal healthy volunteers. The study consists of 12 visits over a 25 week period. Forty five (45) normal healthy subjects will be treated with both levetiracetam (2000 mg/day) and carbamazepine [adjusted to a dose to obtain mid-range anticonvulsant blood level (ABL) with a target ABL = 8.5¿¿g/ml and a range = 6-12 ¿¿g/ml) for 8 weeks each. Each AED treatment period will be followed by a four day taper and washout period off AED for the remainder of the month. Cognitive and behavioral function testing along with safety testing will be conducted at pretreatment baseline, the end of each randomization AED maintenance period, and after the final washout period. SPECIFIC AIMS: The overall aim of the proposed study is to compare the effects of levetiracetam versus carbamazepine on neuropsychologic function after eight weeks treatment in healthy adults. We also plan to compare the safety and tolerability of levetiracetam versus carbamazepine in healthy adults. Hypothesis: Our hypothesis is that the cognitive effects of carbamazepine will be greater than those of levetiracetam.