PILOT STUDY OF ST JOHNS WORT IN JUVENILE DEPRESSION

描述(改编自申请者摘要)：重度抑郁症是一种 常见的、使人衰弱并可能危及生命的疾病。主修 抑郁症是儿童和青少年中的一种常见疾病。虽然 许多药物抗抑郁药已被证明对 改善成年人的抑郁症状，目前还没有 美国已表明的药物抗抑郁药 供儿童或青少年使用。金丝桃属植物提取物 贯叶连翘通常被称为圣约翰草(SJW)。SJW是一家 德国流行的抑郁症自然疗法。SJW最近 在这个国家受到了极大的关注，无论是科学研究还是 将媒体作为一种可能的非药物治疗抑郁症的方法。 大量双盲研究表明，生姜丸优于安慰剂。 在减轻抑郁症成年人症状方面的作用。对成人进行的对照研究 还描述了SJW具有与药物类似的抗抑郁作用 抗抑郁药，但SJW具有更好的副作用特征。然而， 之前发表的关于成人SJW的研究通常有 方法上的缺陷。这些方法论上的考虑有 妨碍了对SJW的疗效得出明确结论 患有严重抑郁症的成年人。自然疗法和其他形式的替代疗法 药物通常用于儿童和青少年(包括SJW)。 我们发现SJW作为一种可能的治疗方法引起了极大的兴趣 治疗年轻人的抑郁症。据传闻，给SJW做过手术的父母 对他们的烦躁不安的孩子描述了显著的治疗益处 来自SJW。不幸的是，几乎没有数据支持或驳斥使用 SJW在年轻人中。目前还没有科学研究或报告 它们描述了SJW在儿童或青少年中的使用情况。这个 本项目的目的是检查有效性、安全性和 SJW在儿童和青少年中的耐受性。这将通过以下方式完成 进行一项为期8周的SJW探索性、开放标签、灵活剂量研究 6-16岁的青少年。如果被证明是治疗抑郁症的一种有希望的疗法 青年们，这项工作将提供必要的数据，为设计一种 随机临床试验。

DESCRIPTION (Adapted from Applicant's Abstract): Major depression is a common, debilitating and potentially life-threatening disorder. Major depression is a common disorder in both children and adolescents. Although many pharmaceutical antidepressants have been shown to have efficacy in ameliorating symptoms of depression in adults, there is currently no pharmaceutical antidepressant that has been indicated in the United States for use in children or adolescents. The extract from the plant Hypericum perforatum is commonly referred to as St. John's Wort (SJW). SJW is a popular naturotherapy treatment for depression in Germany. SJW has recently received significant attention in this country in both the scientific and lay media as a possible non-pharmaceutical treatment for depression. Numerous double-blind studies have indicated that SJW is superior to placebo in reducing symptoms in depressed adults. Controlled studies in adults have also described that SJW has similar antidepressant effects as pharmaceutical antidepressants, but SJW possesses a superior side effect profile. However, previously published studies of SJW in adults have generally had methodological shortcomings. These methodological considerations have prevented definitive conclusions to be drawn about the efficacy of SJW in adults with major depression. Naturotherapy and other forms of alternative medicine are often administered to children and adolescents (including SJW). We have found that there is great interest in SJW as a possible treatment for depression in the young. Anecdotally, parents who have administered SJW to their dysphoric children have described significant therapeutic benefit from SJW. Unfortunately, there are few data to support or refute the use of SJW in the young. There are currently no scientific studies or reports which have described the use of SJW in either children or adolescents. The purpose of this project is to examine the effectiveness, safety, and tolerability of SJW in both children and adolescents. This will be done by performing an exploratory, open-label, 8-week, flexible-dose study of SJW in youths ages 6-16 years. If shown to be a promising treatment for depressed youths, this work will provide the necessary data to inform the design of a randomized clinical trial.