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

J Affect Disord. 2014 Feb;155:216-22. doi: 10.1016/j.jad.2013.11.003. Epub 2013 Nov 16.


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.

Limitations: Relatively small sample size and short observational period were the major limitations of this study.

Conclusion: 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.

Keywords: Clinical trial; Crocus sativus L.; Depression; Percutaneous coronary intervention; Saffron.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antidepressive Agents / adverse effects
  • Antidepressive Agents / therapeutic use*
  • Crocus* / adverse effects
  • Depression / drug therapy*
  • Double-Blind Method
  • Female
  • Fluoxetine / adverse effects
  • Fluoxetine / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / statistics & numerical data*
  • Phytotherapy* / adverse effects
  • Plant Extracts / adverse effects
  • Plant Extracts / therapeutic use
  • Psychiatric Status Rating Scales
  • Severity of Illness Index*
  • Treatment Outcome


  • Antidepressive Agents
  • Plant Extracts
  • Fluoxetine