Anxiety and Traumatic Stress Disorders Research Program, University of California San Diego, 8939 Villa La Jolla Drive, Suite 200, La Jolla, CA 92037, USA.
J Clin Psychiatry. 2010 May;71(5):627-31. doi: 10.4088/JCP.08m04949gre. Epub 2009 Dec 15.
This multicenter, double-blind, placebo-controlled, 2-arm, parallel-group study was carried out to determine the effectiveness and safety of the novel anticonvulsant levetiracetam for the treatment of generalized social anxiety disorder (GSAD).
After a 1-week, single-blind, placebo run-in period, 217 adult outpatients meeting DSM-IV criteria for social anxiety disorder, generalized type, were randomly assigned (1:1) to 12 weeks of double-blind treatment with either levetiracetam (n = 111) or placebo (n = 106). Participants were required to have scores of >or= 60 on the Liebowitz Social Anxiety Scale (LSAS) and a total score of <or= 17 on the 17-item Hamilton Depression Rating Scale (HDRS). The primary outcome measure was mean change from baseline on LSAS total score. Levetiracetam was initiated at 250 mg/d and flexibly titrated up to a maximum dose of 3,000 mg/d (1,500 mg bid). Dosage was held stable for the last 6 weeks of treatment. The study was conducted from September 2003 to June 2004.
No statistically significant difference was found between the adjusted mean changes in LSAS score for levetiracetam (-24.4) and placebo (-28.7) using an efficacy intent-to-treat, last- observation-carried-forward analysis. Rates of response (>or= 30% reduction in LSAS score) were similar with 41.3% (levetiracetam) and 46.6% (placebo). No significant between-group differences were found on secondary outcome measures, which included changes in Sheehan Disability Scale, Clinical Global Impression of Change, and HDRS scores.
Although well-tolerated, levetiracetam failed to separate from placebo in this trial for the treatment of moderate to severe GSAD.
这项多中心、双盲、安慰剂对照、2 臂、平行组研究旨在确定新型抗惊厥药左乙拉西坦治疗广泛性社交焦虑症（GSAD）的有效性和安全性。
在为期 1 周的单盲、安慰剂导入期后，符合 DSM-IV 社交焦虑障碍、广泛性类型标准的 217 名成年门诊患者被随机分为（1:1）接受 12 周的双盲治疗，分别接受左乙拉西坦（n=111）或安慰剂（n=106）。患者需要在 Liebowitz 社交焦虑量表（LSAS）上的得分>or=60，在 17 项汉密尔顿抑郁评定量表（HDRS）上的总分<or=17。主要结局指标为 LSAS 总分从基线的平均变化。左乙拉西坦起始剂量为 250mg/d，灵活滴定至最大剂量 3000mg/d（1500mg bid）。在治疗的最后 6 周维持剂量稳定。该研究于 2003 年 9 月至 2004 年 6 月进行。
使用疗效意向治疗、最后观察结转分析，左乙拉西坦（-24.4）和安慰剂（-28.7）的 LSAS 评分调整后平均变化之间无统计学显著差异。LSAS 评分>or=30%的反应率相似，分别为 41.3%（左乙拉西坦）和 46.6%（安慰剂）。在次要结局测量中，包括 Sheehan 残疾量表、临床总体印象变化和 HDRS 评分的变化，均未发现组间有显著差异。
尽管耐受性良好，但在这项试验中，左乙拉西坦在治疗中重度 GSAD 方面未能与安慰剂区分开来。
