Effectiveness and Tolerability of Korean Red Ginseng Augmentation in Major Depressive Disorder Patients with Difficult-to-treat in Routine Practice

Objective: To test clinical effectiveness and tolerability of Korean Red Ginseng augmentation (RGA) in major depressive disorder (MDD) patients with difficult-to-treat. Methods: Thirty six patients were enrolled in this 6 weeks, prospective, clinical trial. Rating scales were Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire-15, Clinical Global Impression-improvement (CGI-I), and Patient Satisfaction Score. The primary endpoint was a remission rate measured by MADRS score at the end of study (≤ 10). Clinical outcomes and tolerability were assessed at baseline, week 2, and week 6. Results: Among 36 patients, 26 patients completed the study and 28 patients had post-baseline visit data. The remission rate by MADRS score was 39.3% (11/28) and 57.1% by CGI-I scores of 1 or 2 at the end of the study. The mean change of MADRS score was significantly decreased by 44.4% from baseline to the end of study. The most frequent adverse events were headache (7/28, 25.0%) during the study. Conclusion: Our study indicates the putative effectiveness and tolerability of RGA for treating MDD with difficult-to-treat in clinical practice. However, adequately powered, randomized, controlled trials will be needed to confirm these results.