Rhodiola Rosea Therapy for Major Depressive Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial
|Jun J Mao1,2,3*, Qing S Li1, Irene Soeller1, Sharon X Xie2 and Jay D Amsterdam4|
|1Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA|
|2Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA|
|3Abramson Cancer Center, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA|
|4Depression Research Unit, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA|
|Corresponding Author :||Jun J Mao, MD, MSCE
Department of Family Medicine and Community Health
University of Pennsylvania, 227 Blockley Hall
423 Guardian Drive, Philadelphia, Pennsylvania 19104, USA
E-mail: [email protected]
|Received May 13, 2014; Accepted June 18, 2014; Published June 20, 2014|
|Citation: Mao JJ, Li QS, Soeller I, Xie SX, Amsterdam JD (2014) Rhodiola Rosea Therapy for Major Depressive Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Trials 4:170. doi:10.4172/2167-0870.1000170|
|Copyright: © 2014 Mao JJ, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
Background: Rhodiola rosea (R. 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 R. rosea for the treatment of major depressive disorder (MDD). This study seeks to evaluate the safety and efficacy of R. rosea 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 R. rosea 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.
Discussion: This study will provide valuable preliminary information on the safety and efficacy data of R. rosea versus conventional antidepressant therapy of MDD. It will also inform additional hypotheses and study design of future, fully powered, phase III clinical trials with R. rosea to determine its safety and efficacy in MDD.