Department of Psychiatry, Yale University, New Haven, Connecticut, USA.
J Clin Psychiatry. 2011 Jun;72(6):744-50. doi: 10.4088/JCP.09m05659gre. Epub 2010 Oct 19.
To study the efficacy of adjunctive levetiracetam therapy compared with placebo in the treatment of subjects with depression with bipolar disorder.
This double-blind, placebo-controlled clinical trial randomly assigned outpatients with bipolar disorder type I and type II who were experiencing a major depressive episode (Structured Clinical Interview for DSM-IV Axis I Disorders-Clinician Version criteria) to treatment with either placebo or adjunctive levetiracetam (up to 2,500 mg/d flexibly dosed) for 6 weeks. The subjects were recruited from October 2005 to June 2008. The primary efficacy measure was mean change from baseline to week 6 in the Hamilton Depression Rating Scale (21-item). Secondary efficacy assessments included the Montgomery-Åsberg Depression Rating Scale, the Beck Depression Inventory, the Clinical Global Impressions-Bipolar Version scale, the Hamilton Anxiety Rating Scale, and the Young Mania Rating Scale.
Of 42 subjects randomly assigned to placebo or drug, 32 received at least 1 postbaseline assessment and thus were included in the analysis. The mean (SD) levetiracetam daily dose at endpoint evaluation was 1,132 (425) mg/d. There was no significant difference in the mean change from baseline to week 6 in the Hamilton Depression Rating Scale scores for levetiracetam compared with placebo. There were no significant differences in any of the secondary outcome measures.
Levetiracetam adjunctive therapy was not superior to placebo in the short-term treatment of subjects with depression with bipolar disorder in the population studied.
Clinicaltrials.gov Identifier: NCT00566150.
研究与安慰剂相比，辅助左乙拉西坦治疗双相情感障碍抑郁患者的疗效。
这是一项双盲、安慰剂对照的临床试验，将 42 例双相 I 型和 II 型障碍且正在经历重度抑郁发作的门诊患者（DSM-IV 轴 I 障碍临床定式访谈-临床版标准）随机分配，接受为期 6 周的安慰剂或辅助左乙拉西坦（灵活剂量高达 2500mg/d）治疗。研究对象于 2005 年 10 月至 2008 年 6 月招募。主要疗效指标是汉密尔顿抑郁量表（21 项）从基线到第 6 周的平均变化。次要疗效评估包括蒙哥马利-阿斯伯格抑郁评定量表、贝克抑郁量表、临床总体印象-双相版本量表、汉密尔顿焦虑量表和 Young 躁狂评定量表。
42 例随机分配至安慰剂或药物组的患者中，有 32 例至少接受了 1 次基线后评估，因此纳入分析。终点评估时左乙拉西坦的平均（SD）日剂量为 1132（425）mg/d。左乙拉西坦组与安慰剂组相比，汉密尔顿抑郁量表评分从基线到第 6 周的平均变化无显著差异。任何次要结局指标均无显著差异。
在研究人群中，与安慰剂相比，左乙拉西坦辅助治疗在双相情感障碍抑郁患者的短期治疗中并无优势。
Clinicaltrials.gov 标识符：NCT00566150。
