Red Yeast Rice As an Adjunct to Sertraline for Treatment of Depression in Patients With Percutaneous Coronary Intervention: Placebo-Controlled Trial Publisher



Divsalar P^{1, 2} ; Noorbala AA¹ ; Moazenzadeh E³ ; Jafarinia M¹ ; Shakiba M^{1, 4} ; Shahmansouri N¹ ; Ghazizadehhashemi M⁵ ; Etesam F¹ ; Akhondzadeh S³ Show Affiliations
Source: Advances in Integrative Medicine Published:2018

Abstract

Objectives: Red 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. Design: This was a 6-week double-blind placebo-controlled randomized clinical trial. Setting: Participants 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 ≤ 80 mg/dL. Interventions: Patients received sertraline (200 mg/day) plus either red yeast rice commercially available capsules (2400 mg/day) containing 10.05 mg/day lovastatin or placebo. Main outcome measures: The primary outcome was the difference in mean change of the HDRS score from baseline to endpoint between the two treatment arms. Results: The 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. Conclusions: This 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. © 2018 Elsevier Ltd