Mao Jun J, Li Qing S, Soeller Irene, Xie Sharon X, Amsterdam Jay D
Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA ; Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA ; Abramson Cancer Center, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
J Clin Trials. 2014 Jun 20;4:170. doi: 10.4172/2167-0870.1000170.
Rhodiola rosea (), a botanical of both western and traditional Chinese medicine, has been used as a folk remedy for improving stamina and reducing stress. However, few controlled clinical trials have examined the safety and efficacy of for the treatment of major depressive disorder (MDD). This study seeks to evaluate the safety and efficacy of in a 12-week, randomized, double-blind, placebo-controlled, parallel group study design.
METHODS / DESIGN: Subjects with MDD not receiving antidepressant therapy will be randomized to either extract 340-1,360 mg daily; sertraline 50-200 mg daily, or placebo for 12 weeks. The primary outcome measure will be change over time in the mean 17-item Hamilton Depression Rating score. Secondary outcome measures will include safety and quality of life ratings. Statistical procedures will include mixed-effects models to assess efficacy for primary and secondary outcomes.
This study will provide valuable preliminary information on the safety and efficacy data of versus conventional antidepressant therapy of MDD. It will also inform additional hypotheses and study design of future, fully powered, phase III clinical trials with to determine its safety and efficacy in MDD.
红景天，一种西方医学和传统中医都使用的植物，一直被用作提高耐力和减轻压力的民间疗法。然而，很少有对照临床试验研究其治疗重度抑郁症（MDD）的安全性和有效性。本研究旨在通过一项为期12周的随机、双盲、安慰剂对照、平行组研究设计，评估其安全性和有效性。
方法/设计：未接受抗抑郁治疗的MDD患者将被随机分为三组，分别每日服用红景天提取物340 - 1360毫克；每日服用舍曲林50 - 200毫克，或服用安慰剂，为期12周。主要结局指标将是17项汉密尔顿抑郁量表评分随时间的变化。次要结局指标将包括安全性和生活质量评分。统计程序将包括混合效应模型，以评估主要和次要结局的疗效。
本研究将提供关于红景天与MDD传统抗抑郁治疗相比的安全性和有效性数据的有价值的初步信息。它还将为未来关于红景天的、有足够效力的III期临床试验的其他假设和研究设计提供信息，以确定其在MDD中的安全性和有效性。
