Comparison of petal of Crocus sativus L. and fluoxetine in the treatment of depressed outpatients: A pilot double-blind randomized trial Afshin Akhondzadeh Basti a , Esmail Moshiri b , Ahamad-Ali Noorbala c , Amir-Hossein Jamshidi d , Seyed Hesameddin Abbasi e , Shahin Akhondzadeh c, ⁎ a Department of Food Hygiene, Faculty of Veterinary Medicine, University of Tehran, Tehran, Iran b Department of Anesthesiology, Arak University of Medical Sciences, Arak, Iran c Pychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran d Deputy for Drug and Food, Ministry of Health and Medical Education, Iran e Research Unit, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran Received 1 September 2006; received in revised form 7 November 2006; accepted 8 November 2006 Available online 15 December 2006 Abstract Depression is one of the most common neuropsychiatric conditions, with a lifetime prevalence approaching 17%. Although a variety of pharmaceutical agents is available for the treatment of depression, psychiatrists find that many patients cannot tolerate the side effects, do not respond adequately, or finally lose their response. On the other hand, many herbs with psychotropic effects have far fewer side effects. They can provide an alternative treatment or be used to enhance the effect of conventional antidepressants. A number of recent preclinical and clinical studies indicate that stigma and petal of Crocus sativus have antidepressant effect. Our objective was to compare the efficacy of petal of C. sativus with fluoxetine in the treatment of depressed outpatients in an 8-week pilot double-blind randomized trial. Forty adult outpatients who met the DSM- IV criteria for major depression based on the structured clinical interview for DSM- IV participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. In this double-blind and randomized trial, patients were randomly assigned to receive capsule of petal of C. sativus 15 mg bid (morning and evening) (Group 1) and fluoxetine 10 mg bid (morning and evening) (Group 2) for a 8-week study. At the end of trial, petal of C. sativus was found to be effective similar to fluoxetine in the treatment of mild to moderate depression (F = 0.03, d.f. =1, P = 0.84). In addition, in the both treatments, the remission rate was 25%. There were no significant differences in the two groups in terms of observed side effects. The present study is supportive of other studies which show antidepressant effect of C. sativus. © 2006 Elsevier Inc. All rights reserved. Keywords: Crocus sativus; Depression; Fluoxetine; Herbal medicine; Petal 1. Introduction Depression is a major worldwide health problem. Indeed, by 2020, depressive disorders are estimated to represent the second largest disease burden worldwide (Judd, 1995; Donoghue and Tylee, 1996; De Smet and Nolen, 1996; Demyttenaere, 1997). Although a variety of pharmaceutical agents is available for the treatment of depression, psychiatrists find that many patients cannot tolerate the side effects, do not respond adequately, or finally lose their response (Richelson, 1994; Demyttenaere, 1997; MacDonald, 1997). On the other hand, many herbs with psychotropic effects have far fewer side effects. They can provide an alternative treatment or be used to enhance the effect of conventional antidepressants (Ernst, 1995; De Smet and Nolen, 1996). A number of studies showed that herbal medicine may be as effective as conventional antidepressant treatment among patients with mild and moderate depression (Ernst, 1995; Linde et al., 2005). Saffron (stigma of Crocus sativus) is the world's most expensive spice and apart from its traditional value as a food additive recent studies indicate its potential as an anti-cancer agent Progress in Neuro-Psychopharmacology & Biological Psychiatry 31 (2007) 439 – 442 www.elsevier.com/locate/pnpbp Abbreviations: HAM-D, Hamilton Rating Scale for Depression; DSM, Diagnostic and Statistical Manual of Mental Disorders; ITT, Intention to Treat; LOCF, Last Observation Carried Forward. ⁎ Corresponding author. No: 29, 39th Street, Gisha Street, Tehran 14479, Iran. Tel.: +98 21 88281866; fax: +98 21 55419113. E-mail address: s.akhond@neda.net (S. Akhondzadeh). 0278-5846/$ - see front matter © 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.pnpbp.2006.11.010