Red yeast rice as an adjunct to sertraline for treatment of depression in patients with percutaneous coronary intervention: Placebo-controlled trial

Abstract

ObjectivesRed yeast rice (RYR) has demonstrated neuroprotective effects in animal studies. The aim of this study was to access the efficacy of RYR for treatment of depression in patients with recent history of percutaneous coronary intervention. DesignThis was a 6-week double-blind placebo-controlled randomized clinical trial. SettingParticipants included outpatient men and women aged 18 to 60 years old with history of coronary angioplasty, diagnosis of major depressive disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), and Hamilton Depression Rating Scale (HDRS) score of ≥20. Candidates were excluded in case of any other DSM-V disorders, use of lipid lowering agents in the last two weeks, elevated serum aminotransferases or serum LDL≤80mg/dL. InterventionsPatients received sertraline (200mg/day) plus either red yeast rice commercially available capsules (2400mg/day) containing 10.05mg/day lovastatin or placebo. Main outcome measuresThe primary outcome was the difference in mean change of the HDRS score from baseline to endpoint between the two treatment arms. ResultsThe primary outcome approached significance (Mean difference in score change(CI95%)=−1.24 (−2.51 to 0.03), p=.056) and was accompanied by a significant time × treatment interaction effect [Two-way ANOVA: F (df, mean square)=4.42 (2, 13.687), p=.015]. There was no significant difference between the two treatment arms in terms of lipid profile, liver function tests, or incidence of adverse events. ConclusionsThis is the first report on the benefits of RYR in treatment of depression. Future studies are warranted to confirm our findings and scrutinize the mechanisms of action.