Rhodiola Rosea Therapy for Major Depressive Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial

BACKGROUND: in a 12-week, randomized, double-blind, placebo-controlled, parallel group study design. METHODS / DESIGN: 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: to determine its safety and efficacy in MDD.