title: A randomized, double-blind, clinical trial comparing the efficacy and safety of Crocus sativus L. with fluoxetine for improving mild to moderate depression in post percutaneous coronary intervention patients.
abstract: OBJECTIVE
  A significant correlation exists between coronary artery diseases and depression. The aim of this trial was to compare the efficacy and safety of saffron versus fluoxetine in improving depressive symptoms of patients who were suffering from depression after performing percutaneous coronary intervention (PCI).
  
  
  METHODS
  In this randomized double-blind parallel-group study, 40 patients with a diagnosis of mild to moderate depression who had undergone PCI in the last six months were randomized to receive either fluoexetine (40mg/day) or saffron (30mg/day) capsule for six weeks. Participants were evaluated by Hamilton depression rating scale (HDRS) at weeks 3 and 6 and the adverse events were systemically recorded.
  
  
  RESULTS
  By the study endpoint, no significant difference was detected between two groups in reduction of HDRS scores (P=0.62). Remission and response rates were not significantly different as well (P=1.00 and P=0.67; respectively). There was no significant difference between two groups in the frequency of adverse events during this trial.
  
  
  CONCLUSIONS
  Relatively small sample size and short observational period were the major limitations of this study.
  
  
  CONCLUSIONS
  Short-term therapy with saffron capsules showed the same antidepressant efficacy compared with fluoxetine in patients with a prior history of PCI who were suffering from depression.
authors.affiliation: Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Nazila
authors.initials: N
authors.lastname: Shahmansouri
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Farokhnia
authors.affiliation: Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran; Family Health Research Center, Iranian Petroleum Industry Health Research Institute, Tehran, Iran.
authors.forename: Seyed-Hesammeddin
authors.initials: SH
authors.lastname: Abbasi
authors.affiliation: Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Seyed Ebrahim
authors.initials: SE
authors.lastname: Kassaian
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Ahmad-Ali
authors.initials: AA
authors.lastname: Noorbala Tafti
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Gougol
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Habibeh
authors.initials: H
authors.lastname: Yekehtaz
authors.affiliation: Razi Vaccine and Serum Research Institute, Karaj, Iran.
authors.forename: Saeedeh
authors.initials: S
authors.lastname: Forghani
authors.affiliation: Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mehran
authors.initials: M
authors.lastname: Mahmoodian
authors.affiliation: Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Sepideh
authors.initials: S
authors.lastname: Saroukhani
authors.affiliation: Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Akram
authors.initials: A
authors.lastname: Arjmandi-Beglar
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: s.akhond@neda.net.
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D027622:Crocus / Q000009:adverse effects; D003863:Depression / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000706:statistics & numerical data*; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D010936:Plant Extracts; D005473:Fluoxetine
keywords: Clinical trial; Crocus sativus L.; Depression; Percutaneous coronary intervention; Saffron