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

background: 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. objective: the goal of this trial was to assess the safety of concomitant administration of saffron and ssri in patients with major depressive disorder (mdd). methods: 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. results: 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. conclusion: this preliminary study provides safety evidences of concurrent intake of saffron and ssri.