Changes in brain function (quantitative EEG cordance) during placebo lead-in and treatment outcomes in clinical trials for major depression
Changes in brain function (quantitative EEG cordance) during placebo lead-in and treatment outcomes in clinical trials for major depression
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DOI：
10.1176/appi.ajp.163.8.1426
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发表时间：
2006-08-01
影响因子：
17.7
通讯作者：
Cook, Ian A.
中科院分区：
文献类型：
--
作者：
Hunter, Aimee M.;Leuchter, Andrew F.;Cook, Ian A.
目的：最早在开始用药后 48 小时即可检测到的前额叶脑电图 (EEG) 一致性下降与重度抑郁症治疗试验的临床结果相关。安慰剂导入阶段大脑变化与药物治疗结果之间的关系尚不清楚。作者推测，安慰剂导入阶段前额叶一致性的降低与接受抗抑郁药物治疗的受试者更好的临床结果相关。 方法：汇总了来自两项独立双盲安慰剂对照试验的 51 名患有重度抑郁症的成年人的数据。在使用药物（氟西汀 20 mg 或文拉法辛 150 mg）或安慰剂随机治疗 8 周之前，先进行为期 1 周的单盲安慰剂导入阶段。作者在基线和安慰剂导入期结束时获得了定量脑电图一致性测量值。使用多元线性回归分析检查安慰剂导入期结束时的区域一致性变化与临床结果（最终的 17 项汉密尔顿抑郁量表评分）之间的关系。 结果：正如假设的那样，安慰剂导入期前额叶一致性的下降与随机分配到药物治疗的受试者中较低的最终汉密尔顿抑郁量表评分相关。前额叶的变化解释了最终汉密尔顿抑郁量表评分的 19% 差异。结论：安慰剂导入期间的神经生理学变化可以作为重度抑郁症临床试验中最终治疗结果的非药效生物标志物。
Objective: Decreases in prefrontal electroencephalogram (EEG) cordance that are detectable as early as 48 hours after the start of medication have been related to clinical outcome in treatment trials for major depressive disorder. The relationship between brain changes during the placebo lead-in phase and medication treatment outcome is unknown. The authors hypothesized that decreases in prefrontal cordance during the placebo lead-in phase would be associated with better clinical outcome in subjects treated with antidepressants.Method: Data were pooled examining 51 adults with major depressive disorder from two independent double-blind placebo-controlled trials. A 1-week singleblind placebo lead-in phase preceded 8 weeks of randomized treatment with medication (fluoxetine 20 mg or venlafaxine 150 mg) or placebo. The authors obtained quantitative EEG cordance measures at baseline and at the end of the placebo lead-in period. Relationships between regional cordance changes at the end of the placebo lead-in period and clinical outcome (the final 17-item Hamilton Rating Scale for Depression scores) were examined using multiple linear regression analysis.Results: As hypothesized, decreases in prefrontal cordance during the placebo lead-in period were associated with lower final Hamilton depression scale scores in subjects randomly assigned to medication. Prefrontal changes explained 19% of the variance in final Hamilton depression scale scores.Conclusions: Neurophysiological changes during a placebo lead-in period may serve as nonpharmacodynamic biomarkers of eventual treatment outcomes in clinical trials for major depressive disorder.