Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: a pilot double-blind randomized trial [ISRCTN45683816].
BACKGROUND
The morbidity and mortality associated with depression are considerable and continue to increase. Depression currently ranks fourth among the major causes of disability worldwide, after lower respiratory infections, prenatal conditions, and HIV/AIDS. Crocus sativus L. is used to treat depression. Many medicinal plants textbooks refer to this indication whereas there is no evidence-based document. Our objective was to compare the efficacy of stigmas of Crocus sativus (saffron) with imipramine in the treatment of mild to moderate depression in a 6-week pilot double-blind randomized trial.


METHODS
Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition 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, single-center trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (TDS) (Group 1) and capsule of imipramine 100 mg/day (TDS) (Group 2) for a 6-week study.


RESULTS
Saffron at this dose was found to be effective similar to imipramine in the treatment of mild to moderate depression (F = 2.91, d.f. = 1, P = 0.09). In the imipramine group anticholinergic effects such as dry mouth and also sedation were observed more often that was predictable.


CONCLUSIONS
The main overall finding from this study is that saffron may be of therapeutic benefit in the treatment of mild to moderate depression. To the best of our knowledge this is the first clinical trial that supports this indication for saffron. A large-scale trial with placebo control is warranted.
Akhondzadeh
Shahin
S
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13185, Iran. s.akhond@neda.net
Fallah-Pour
Hasan
H
Afkham
Khosro
K
Jamshidi
Amir-Hossein
AH
Khalighi-Cigaroudi
Farahnaz
F
D000328:Adult; D027622:Crocus; D003863:Depression / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007099:Imipramine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008517:Phytotherapy; D010865:Pilot Projects; D028321:Plant Preparations / Q000627:therapeutic use*; D016896:Treatment Outcome; D014987:Xerostomia / Q000139:chemically induced
D028321:Plant Preparations; D007099:Imipramine