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Background and purpose: Depressive disorder is a serious, potentially recurrent and very common in clinical practice with estimated lifetime prevalence of 21% among the general population and approximately 11.3 of adults afflicted during a year. Saffron is a traditional spice which is used as a food additive. Recent studies indicate several therapeutic effects for saffron in psychiatric disorders, especially depression. Material and methods: We compared the efficacy of fluoxetine plus 40 mg hydro- alcoholic extract of crocus sativus and fluoxetine plus 80 mg hydro-alcoholic extract of crocus sativus, in a six-week double- blind, randomized clinical trial in the treatment of mild to moderate depressive disorders. Sixty adult patients were chosen who met the diagnostic and statistical criteria for mental disorders. Data was collected using Hamilton Depression Rating Scale, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), and structured clinical interviews. Patients were randomly assigned to receive either fluoxetine 30 mg/ day (20 mg morning, 1o mg noon) and capsules of Saffron 40 mg/day (BD) (group 1) or fluoxetine 30 mg/day and Saffron 8o mg/day (group 2). Results: Saffron was found effective in both groups, however, significant differences were found in the group receiving 80 mg saffron capsules (P< 0.05). The two groups did not show any significant difference in having side effects. Conclusion: This study showed the efficacy of 80 mg saffron daily without the raise of side events in the treatment of mild to moderate depression. However, more large-scaled controlled clinical trials are recommended to confirm these results.

Keywords: Crocus Sativus, Depression, Fluoxetine

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