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征，其终生患病率为1- 2%。越来越多的证据支持强迫症病因学的多巴胺能假说，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，无反应或部分反应也是作用。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中的脱落率分别为23%、24%、27%和20%。圣约翰草（贯叶连翘）作为治疗轻度至中度抑郁症的药物，在世界范围内引起了相当大的兴趣。迄今为止，已有23项随机试验表明，SJW治疗轻中度抑郁症门诊患者比安慰剂更有效。SJW耐受性良好，在一项大型药物监测研究中仅在2.5%的病例中观察到轻度副作用。SJW的作用机制是通过抑制5-羟色胺的突触体摄取来推测的，因此有一种建议，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名受试者接受固定剂量450 mg金丝桃素每日两次，发现从基线到终点的显著变化，平均Y-BOCS变化为7.4分（p=.002）。12名受试者中有5名先前未能对SSRI试验作出反应。本研究将是一项为期12周、双盲、安慰剂对照平行组研究。本研究旨在检查SJW与安慰剂相比的疗效和安全性。将50名受试者随机分配至SJW（Alterra麸皮，450 mg，1.35金丝桃素）或匹配安慰剂组。这将是450 mg bid的固定剂量设计。 将采用意向治疗分析。受试者将每周接受一次评价，持续两周，此后每两周一次。

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.