randomized, double-blind, placebo - controlled study of safety of the adjunctive saffron on sexual dysfunction induced by a selective serotonin reuptake inhibitor

ABSTRACT

Recent studies have indicated potential of saffron for applying in a wide variety of diseases such as psychiatric and neurologic disorders. The concurrent use of saffron with SSRIs can lead to reducing the dose of SSRIs. Saffron at a dose of 200 mg may change some hematological and biochemical parameters. The goal of this trial was to assess the safety of concomitant administration of saffron and SSRI in patients with major depressive disorder [MDD]. Twenty adult outpatients between 18 to 55 years-old with the diagnosis of MDD who were receiving an SSRI for at least 1 month prior to the initiation of the study entered this double-blind trial. They were randomly assigned to receive capsule of saffron [15 mg twice daily] or placebo. Some laboratory parameters were measured at baseline and week 4 of the study. Other side effects checked on a prepared list of side effects, were systematically recorded throughout the study at baseline and on a weekly basis. Saffron as an add-on medication to SSRIs for 4 weeks did not cause any statistically significant changes in laboratory parameters including AST, ALT, ALP, BUN, Cr., FBS, TG, TC, WBC, RBC, Hgb, Ht, PT, INR, and Pl count. This preliminary study provides safety evidences of concurrent intake of saffron and SSRI