title: Rhodiola rosea therapy for major depressive disorder: a study protocol for a randomized, double-blind, placebo- controlled trial.
abstract: 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 ofR. roseafor the treatment of major depressive disorder (MDD). This study seeks to evaluate the safety and efficacy ofR. roseain a 12-week, randomized, double-blind, placebo-controlled, parallel group study design.
  
  
  METHODS
  Subjects with MDD not receiving antidepressant therapy will be randomized to eitherR. roseaextract 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.
  
  
  CONCLUSIONS
  This study will provide valuable preliminary information on the safety and efficacy data ofR. roseaversus conventional antidepressant therapy of MDD. It will also inform additional hypotheses and study design of future, fully powered, phase III clinical trials withR. roseato determine its safety and efficacy in MDD.
authors.affiliation: 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.
authors.forename: Jun J
authors.initials: JJ
authors.lastname: Mao
authors.affiliation: Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
authors.forename: Qing S
authors.initials: QS
authors.lastname: Li
authors.affiliation: Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
authors.forename: Irene
authors.initials: I
authors.lastname: Soeller
authors.affiliation: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
authors.forename: Sharon X
authors.initials: SX
authors.lastname: Xie
authors.affiliation: Depression Research Unit, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
authors.forename: Jay D
authors.initials: JD
authors.lastname: Amsterdam
keywords: Alternative Medicine; Botanical Therapy; Depression; Herbal Therapy; Major Depressive Disorder; R. rosea; Rhodiola rosea