affron ®, a standardised extract from saffron (Crocus sativus L.) for the treatment of youth anxiety and depressive symptoms: A randomised, double-blind, placebo-controlled study

J Affect Disord. 2018 May;232:349-357. doi: 10.1016/j.jad.2018.02.070. Epub 2018 Feb 26.

Abstract

Background: Saffron has antidepressant and anxiolytic effects in adults with mild-to-moderate depression. However, this is the first study examining its mood-related effects in teenagers.

Methods: In this 8-week, randomised, double-blind, placebo-controlled study, youth aged 12-16 years, with mild-to-moderate anxiety or depressive symptoms were given tablets containing placebo or a saffron extract (affron®, 14 mg b.i.d). The youth and parent versions of the Revised Child Anxiety and Depression Scale (RCADS) were used as outcome measures.

Results: 80 participants were enrolled and 68 completed the study. Based on youth self-reports, affron® was associated with greater improvements in overall internalising symptoms (p = 0.049), separation anxiety (p = 0.003), social phobia (p = 0.023), and depression (p = 0.016). Total internalising scores decreased by an average of 33% compared to 17% in the placebo group (p = 0.029). However, parental reports of improvements were inconsistent as mean improvements in RCADS scores were greater in the saffron group (40% vs 26%) (p = 0.026), although no other significant differences were identified. affron® was well-tolerated and there was a trend of reduced headaches in participants on the active treatment.

Limitations: The use of a self-report instrument, limited study duration, single treatment dose, and non-clinical sample used in this study limit the generalisability of study findings.

Conclusion: The administration of a standardised saffron extract (affron®) for 8 weeks improved anxiety and depressive symptoms in youth with mild-to-moderate symptoms, at least from the perspective of the adolescent. However, these beneficial effects were inconsistently corroborated by parents.

Keywords: Anxiety; Clinical trial; Depression; Saffron extract; Teenager; Youth.

Publication types

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

MeSH terms

  • Adolescent
  • Antidepressive Agents / therapeutic use
  • Anxiety / complications
  • Anxiety / drug therapy*
  • Anxiety, Separation / complications
  • Anxiety, Separation / drug therapy
  • Child
  • Crocus*
  • Depression / complications
  • Depression / drug therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Parents / psychology
  • Phobia, Social / complications
  • Phobia, Social / drug therapy
  • Phytotherapy*
  • Plant Extracts / therapeutic use*
  • Self Report
  • Treatment Outcome

Substances

  • Antidepressive Agents
  • Plant Extracts