A randomized, double-blind, clinical trial comparing the efficacy and safety of Crocus sativus L. with fluoxetine for improving mild to moderate depression in post percutaneous coronary intervention patients.

Abstract Objective A significant correlation exists between coronary artery diseases and depression. The aim of this trial was to compare the efficacy and safety of saffron versus fluoxetine in improving depressive symptoms of patients who were suffering from depression after performing percutaneous coronary intervention (PCI). Methods In this randomized double-blind parallel-group study, 40 patients with a diagnosis of mild to moderate depression who had undergone PCI in the last six months were randomized to receive either fluoexetine (40 mg/day) or saffron (30 mg/day) capsule for six weeks. Participants were evaluated by Hamilton depression rating scale (HDRS) at weeks 3 and 6 and the adverse events were systemically recorded. Results By the study endpoint, no significant difference was detected between two groups in reduction of HDRS scores ( P =0.62). Remission and response rates were not significantly different as well ( P =1.00 and P =0.67; respectively). There was no significant difference between two groups in the frequency of adverse events during this trial. Limitations Relatively small sample size and short observational period were the major limitations of this study. Conclusion Short-term therapy with saffron capsules showed the same antidepressant efficacy compared with fluoxetine in patients with a prior history of PCI who were suffering from depression.