Zhang Wei, Connor Kathryn M, Davidson Jonathan R T
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA.
J Psychopharmacol. 2005 Sep;19(5):551-3. doi: 10.1177/0269881105056526.
While serotonergic antidepressants are now established as first-line pharamcotherapy for generalized social anxiety disorder (SAD), other agents with different mechanisms have shown promise in treating SAD. The aim of this pilot study is to examine the efficacy and safety of levetiracetam (LEV), an anticonvulsant with calcium channel modulating properties, in treating SAD. Adult outpatients meeting DSM-IV criteria for SAD were randomly assigned (2:1) to double-blind treatment with either LEV (500-3000 mg/day) or placebo (PBO) for 7 weeks. The primary outcome measures were the change from baseline in the Brief Social Phobia Scale (BSPS) and response using the Clinical Global Impression of Improvement scale (CGI-I). The mean (SD) BSPS scores at baseline and endpoint were 45.4 (9.7) and 31.2 (19.7) for LEV (n=9), compared to 43.5 (8.4) and 37.8 (19.9) for PBO (n =7) (ITT; ns). Rates of response were 22% for LEV and 14% for PBO using the CGI-I. Using a BSPS response criterion (>30% reduction), response rates were 44% for LEV and 14% for PBO. The effect sizes of LEV relative to PBO were 0.33 for the BSPS and 0.50 for the LSAS. In summary, the results of this study, while negative on the pre-defined measures, suggest promise for LEV as a new treatment of SAD. Further work should be carried out with larger sample sizes and optimal dosing strategies of the drug.
虽然血清素能抗抑郁药现已成为广泛性社交焦虑障碍（SAD）的一线药物治疗方法，但其他具有不同作用机制的药物在治疗SAD方面也显示出了前景。这项初步研究的目的是检验具有钙通道调节特性的抗惊厥药左乙拉西坦（LEV）治疗SAD的疗效和安全性。符合DSM-IV标准的成年门诊SAD患者被随机分配（2:1）接受为期7周的双盲治疗，分别服用LEV（500 - 3000毫克/天）或安慰剂（PBO）。主要结局指标是简明社交恐惧症量表（BSPS）相对于基线的变化，以及使用临床总体印象改善量表（CGI-I）的反应。LEV组（n = 9）在基线和终点时的平均（标准差）BSPS评分分别为45.4（9.7）和31.2（19.7），而PBO组（n = 7）分别为43.5（8.4）和37.8（19.9）（意向性分析；无显著性差异）。使用CGI-I，LEV的有效率为22%，PBO为14%。使用BSPS反应标准（降低>30%），LEV的有效率为44%，PBO为14%。相对于PBO，LEV在BSPS上的效应大小为0.33，在社交焦虑量表（LSAS）上为0.50。总之，本研究结果虽然在预定义指标上为阴性，但表明LEV作为SAD的一种新治疗方法具有前景。应该用更大的样本量和该药物的最佳给药策略开展进一步研究。
