St. John's Wort vs Placebo in Social Phobia

描述(申请人提供)：社交恐惧症是一种普遍存在的 虚弱的状况，终生患病率为13.3%。 社交恐惧症患者被发现存在功能障碍 教育、就业和社会关系领域的质量较差 以及更多的自杀意念和精神共病。 双盲研究发现苯二氮卓类药物有选择性和非选择性 MAOI抑制剂，几种SSRI，以及抗惊厥药物普瑞巴林和 加巴喷丁是有效的。然而，这些化合物的副作用表明 需要耐受性更好的化合物，例如在帕罗西汀多中心 试验(FDA批准的唯一适应症的药物)，27%的人报告 嗜睡，26%的人恶心，37%的男性报告延迟 射精；34%的患者提前停止了试验。那里有 全世界对圣约翰麦汁(金丝桃)有相当大的兴趣 穿孔)作为治疗轻度到中度抑郁症的一种方法。已经有23个 随机试验表明SJW治疗高血压病比安慰剂更有效 轻至中度抑郁症患者的门诊治疗。SJW很好 仅在2.5%的病例中观察到耐受性和轻微副作用 大型(3250名患者)药物监测研究。药代动力学研究发现 金丝桃对5-羟色胺、多巴胺和GABAα、GABAβ的亲和力 受体，每一个都与社交恐惧症有关，因此有一种 提示SJW可能对这种疾病有效。这将是为期12周的 双盲、安慰剂对照试验，旨在产生效应大小数据 这将被用来确定为最终研究提供动力所需的样本量。 40名患者将被随机分为SJW(LI160)组和匹配的安慰剂组。 这将是一种灵活的剂量设计，从300 mg，tid开始，到最大 每天总共1800毫克。将采用意向治疗分析。科目 将在两周内每周评估一次，然后每两周评估一次。初级阶段 结果衡量标准将是利博维茨从基线到终点的变化 社交焦虑量表。

DESCRIPTION (provided by applicant): Social Phobia is a prevalent and debilitating condition, with a lifetime prevalence rate to be 13.3 percent. Socially phobic patients have been found to be functionally impaired in the areas of education, employment and social relationships, to have poorer quality of life, and increased suicidal ideation and psychiatric comorbidity. Double-blind studies have found benzodiazepines, selective and non-selective MAOI inhibitors, several SSRIs, and the anticonvulsants pregabalin and gabapentin to be effective. However, side effects with these compounds suggests the need for better tolerated compounds, e.g., in the paroxetine multi-center trial (the only drug with an FDA approved indication), 27 percent reported somnolence, 26 percent nausea, and 37 percent of males reported delayed ejaculation; 34 percent of patients discontinued the trial early. There has been considerable worldwide interest in St. John's Wort (SJW) (Hypericum perforatum) as a treatment of mild to moderate depression. There have been 23 randomized trials suggesting SJW is more effective than placebo for the treatment of outpatients with mild to moderate depression. SJW is very well tolerated with mild side effects observed in only 2.5 percent of cases in a large (3250 patients) drug monitoring study. Pharmacokinetic studies have found Hypericum to have affinity for serotonin, dopamine and GABA alpha and GABA beta receptors, each of which have been implicated in social phobia, thus there is a suggestion that SJW may be effective for this disorder. This will be a 12-week, double blind, placebo-controlled trial, designed to generate effect size data that will be used to determine sample size needed to power a definitive study. Forty patients will be randomized to either SJW (LI 160) or matching placebo. This will be a flexible-dose design, starting at 300 mg tid to a maximum of 1800 mg total per day. An intent-to-treat analysis will be employed. Subjects will be evaluated weekly for two weeks, then bi-weekly thereafter. The primary outcome measure will be the change from baseline to endpoint on the Liebowitz Social Anxiety Scale.