R21 Project: St. John's Wort vs. Placebo in OCD

强迫症（OCD）是一种以强迫和强迫为特征的综合症，其终生患病率为1-2%。越来越多的证据支持强迫症病因的5 -羟色胺能假说，导致几种5 -羟色胺再摄取抑制剂（SSRIs）被批准用于治疗这种疾病。然而，即使有足够的剂量和持续时间，无反应或部分反应是作用。此外，SSRIs的副作用促使人们寻找耐受性更好的化合物（例如，氟西汀、氟伏沙明、舍曲林和帕罗西汀的多中心试验的退出率分别为23%、24%、27%和20%）。有相当大的世界范围内的兴趣圣约翰草（SJW）（贯叶连翘）作为治疗轻至中度抑郁症。迄今为止，已有23项随机试验表明，SJW在治疗轻度至中度抑郁症门诊患者方面比安慰剂更有效。在一项大型药物监测研究中，SJW耐受性良好，副作用轻微，仅在2.5%的病例中观察到。SJW的作用机制是通过抑制突触体对5 -羟色胺的摄取来推测的，因此有一种建议认为SJW可能对强迫症有效。最近的一项为期12周的开放标签试验，123名受试者使用固定剂量的450 mg金丝桃素，每天两次，从基线到终点有显著变化，Y-BOCS平均变化为7.4点（p= 0.002）。12名受试者中有5人之前对SSRI试验没有反应。目前的研究将是一项为期12周、双盲、安慰剂对照的平行组研究。本研究的目的是比较SJW与安慰剂的疗效和安全性。50名受试者将被随机分配到SJW （Alterra bran, 450 mg， 1.35金丝桃素）或匹配的安慰剂组。这将是一个固定剂量的设计在450毫克投标。将采用意向治疗分析，受试者将在两周内每周评估一次，之后将改为每两周评估一次。

Obsessive compulsive disorder (OCD), a syndrome characterized by obsessions and compulsions, has a lifetime prevalence of 1-2%. Accumulating evidence in support of the serotonergic hypothesis on the etiology of OCD led to several serotonin reuptake inhibitors (SSRIs) being approved as a treatment for this disorder. However, even with adequate dose and duration non-response or partial response is the role. In addition, side effects with the SSRIs prompt the search for better tolerated compounds (e.g., drop-out rates in the multi-center trials of fluoxetine, fluvoxamine, sertraline, and paroxetine were 23%, 24%, 27%, and 20% respectively. There has been considerable worldwide interest in St. John's Wort (SJW) (Hypericum perforatum) as a treatment from mild to moderate depression. To date, there have been 23 randomized trials suggests 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% of cases in a large drug monitoring study. SJW's mechanism of action is postulated by be via inhibition of the synaptosomal uptake of serotonin, and thus there is a suggestion that SJW may be effective for OCD. A recent 12- week open-label trial with 123 subjects with a fixed dose of 450 mg of hypericin twice daily found a significant change from baseline to endpoint, with a mean Y-BOCS change of 7.4 points (p=.002). Five of the 12 subjects previously failed to respond to a trial with an SSRI. The current study will be a 12-week, double-blind, placebo controlled parallel group study. The purpose of the study is to examine the efficacy and safety of SJW compared to placebo. Fifty subjects will be randomly assigned to SJW (Alterra bran, 450 mg, 1.35 hypericin) or matching placebo. This will be a fixed-dose design at 450 mg bid. An intent-to- treat analysis will be employed Subjects will be evaluated weekly for two weeks than bi-weekly thereafter.