PILOT STUDY OF ST JOHNS WORT IN JUVENILE DEPRESSION

描述（改编自申请人的摘要）：重度抑郁症是一种 一种常见的、使人衰弱的、可能危及生命的疾病。 主要 抑郁症是儿童和青少年的常见疾病。 虽然 许多药物抗抑郁剂已经显示出在 改善成年人抑郁症的症状，目前还没有 在美国已被指定的药物抗抑郁药 用于儿童或青少年。 金丝桃属植物的提取物 贯叶连翘通常被称为圣约翰草（SJW）。 SJW是一个 在德国流行的抑郁症自然疗法。 SJW最近 在这个国家的科学和 层介质作为抑郁症可能的非药物治疗。 大量双盲研究表明，SJW优于安慰剂，但其疗效优于安慰剂，且优于上级 减轻抑郁症的症状。 成人对照研究 还描述了SJW具有与药物类似的抗抑郁作用， 抗抑郁药，但SJW具有优越的上级副作用。 然而，在这方面， 以前发表的成人SJW研究通常有 方法上的缺陷。 这些方法上的考虑 无法得出关于SJW在以下方面疗效的明确结论： 患有重度抑郁症的成年人 自然疗法和其他替代形式 药物通常用于儿童和青少年（包括SJW）。 我们已经发现，有很大的兴趣，在SJW作为一种可能的治疗 年轻人的抑郁症。 有趣的是，那些给SJW的父母 已经描述了显著的治疗效果 从SJW。 不幸的是，很少有数据支持或反驳使用 SJW在年轻的时候。 目前没有科学研究或报告 描述了SJW在儿童或青少年中的使用。 的 该项目的目的是检查有效性，安全性， 儿童和青少年的SJW耐受性。 会来做这项工作 对SJW进行了一项探索性、开放标签、8周、灵活剂量研究， 6-16岁的青少年。 如果被证明是一种有希望的治疗抑郁症的方法 青年，这项工作将提供必要的数据，通知设计一个 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.