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Efficacy of a standardised saffron extract (affron®) as an add-on to antidepressant medication for the treatment of persistent depressive symptoms in adults: A randomised, double-blind, placebo-controlled study

Lopresti, A.L.ORCID: 0000-0002-6409-7839, Smith, S.J., Hood, S.D. and Drummond, P.D. (2019) Efficacy of a standardised saffron extract (affron®) as an add-on to antidepressant medication for the treatment of persistent depressive symptoms in adults: A randomised, double-blind, placebo-controlled study. Journal of Psychopharmacology . In Press.

Link to Published Version: https://doi.org/10.1177/0269881119867703
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Abstract

Background:
As a stand-alone intervention, saffron has efficacy for the treatment of mild-to-moderate depression. However, research as an adjunct agent is limited.

Aims:
The effects of saffron as an adjunct to pharmaceutical antidepressants in adults with persistent depression was investigated.

Methods:
In this eight-week, randomised, double-blind, placebo-controlled study, adults with persistent depression, currently taking a pharmaceutical antidepressant were given a placebo or a saffron extract (affron®, 14 mg b.i.d.). Primary outcome measures included the clinician-rated Montgomery–Åsberg Depression Rating Scale (MADRS) and self-rated MADRS (MADRS-S). Secondary outcome measures included the Antidepressant Side-Effect Checklist (ASEC) and Short Form-36 Health Survey (SF-36).

Results:
Of the 160 participants enrolled, 139 provided usable data. Based on the MADRS, depressive symptoms decreased more in participants taking saffron compared with a placebo, with reductions of 41 and 21%, respectively (p = 0.001). However, scores on the MADRS-S decreased 27 and 26% in the saffron and placebo conditions, respectively (p = 0.831). Saffron was associated with a greater reduction in adverse effects of antidepressants (p = 0.019), although this was non-significant after covarying for baseline values (p = 0.449). Quality of life improved in both groups with no significant between-group differences (p = 0.638).

Conclusion:
Adjunctive administration of a standardised saffron extract (affron®) for eight weeks was associated with a greater improvement in depressive symptoms as measured by the clinician-rated MADRS but not the self-report MADRS-S. Given the conflicting results, further research is needed to clarify the clinical benefits of saffron as an adjunctive treatment for adults with persistent depressive symptoms despite antidepressant drug treatment.

Item Type: Journal Article
Murdoch Affiliation: College of Science, Health, Engineering and Education
Publisher: Sage
Copyright: © 2019 by British Association for Psychopharmacology
URI: http://researchrepository.murdoch.edu.au/id/eprint/51247
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