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首页> 外文期刊>The journal of clinical psychiatry >An Open-Label Study of Levetiracetam for the Treatment of Social Anxiety Disorder.
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An Open-Label Study of Levetiracetam for the Treatment of Social Anxiety Disorder.

机译：左乙拉西坦治疗社交焦虑症的开放标签研究。

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OBJECTIVE: Social anxiety disorder is a disabling condition characterized by excessive fear and avoidance of social and performance situations. While a variety of effective pharmacotherapies exists, many patients do not fully respond to or tolerate available agents. Preclinical and early clinical experience with levetiracetam, a novel anticonvulsant agent, suggests that levetiracetam has anxiolytic properties and a favorable adverse event profile. Levetiracetam thus warrants systematic evaluation as a treatment option for anxiety disorders. METHOD: Twenty adult outpatients who were recruited through advertisement and clinical referral and who met DSM-IV criteria for social anxiety disorder, generalized type, participated in this 8-week open-label, flexible-dose study from November 2002 to December 2003. Participants were required to have scores of >/= 50 on the Liebowitz Social Anxiety Scale (LSAS) and >/= 4 on the Clinical Global Impressions-Severity of Illness scale (CGI-S) at baseline. The presence of comorbid depression and anxiety disorders were permitted as long as social anxiety disorder was the primary disorder. Levetiracetam was initiated at 250 mg/day for the first week and flexibly titrated up to a maximum of 3000 mg/day (1500 mg b.i.d.). The primary outcome measure was change in the LSAS score at endpoint. RESULTS: There was a clinically significant 20.5-point decrease in LSAS scores in the intent-to-treat, last-observation-carried-forward analysis (t = 3.1; p <.01, N = 20). There were also significant reductions in CGI-S (p <.01) and Hamilton Rating Scale for Anxiety (p <.02) scores. CONCLUSIONS: This pilot study supports the safety and potential efficacy of a novel agent, levetiracetam, for the treatment of social anxiety disorder. Larger controlled trials are warranted to confirm these results.
机译：目的：社交焦虑症是一种残疾状况，其特征是过度恐惧以及避免社交和绩效状况。尽管存在多种有效的药物治疗方法，但许多患者并未完全响应或耐受可用的药物。新型抗惊厥药左乙拉西坦的临床前和早期临床经验表明，左乙拉西坦具有抗焦虑作用和良好的不良事件特征。因此，左乙拉西坦值得系统评价作为焦虑症的治疗选择。方法：从2002年11月至2003年12月，通过广告和临床转诊招募的，符合DSM-IV社交焦虑症一般型标准的20名成人门诊参加了为期8周的开放标签，灵活剂量研究。在基线时，要求他们在利勃维茨社交焦虑量表（LSAS）上得分> / = 50，在临床总体印象-疾病严重程度量表（CGI-S）上得分> / = 4。只要社交焦虑症是原发性疾病，就允许并存抑郁症和焦虑症。在第一周以250毫克/天的剂量开始左乙拉西坦，并灵活滴定至最大3000毫克/天（1500毫克b.i.d.）。主要结局指标是终点处LSAS得分的变化。结果：在意向性治疗，最后观察携带的分析中，LSAS得分在临床上显着降低了20.5分（t = 3.1; p <.01，N = 20）。 CGI-S（p <.01）和汉密尔顿焦虑量表评分（p <.02）得分也明显降低。结论：该初步研究支持新型药物左乙拉西坦治疗社交焦虑症的安全性和潜在疗效。必须进行较大的对照试验才能证实这些结果。

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