TY - JOUR
T1 - Efficacy of a standardised saffron extract (affron®) as an add-on to antidepressant medication for the treatment of persistent depressive symptoms in adults
T2 - A randomised, double-blind, placebo-controlled study
AU - Lopresti, Adrian L.
AU - Smith, Stephen J.
AU - Hood, Sean D.
AU - Drummond, Peter D.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - 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.
AB - 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.
KW - adjunct treatment
KW - antidepressant
KW - Depression
KW - herbal
KW - saffron
UR - http://www.scopus.com/inward/record.url?scp=85072015009&partnerID=8YFLogxK
U2 - 10.1177/0269881119867703
DO - 10.1177/0269881119867703
M3 - Article
C2 - 31475623
AN - SCOPUS:85072015009
VL - 33
SP - 1415
EP - 1427
JO - Journal of Psychopharmacology
JF - Journal of Psychopharmacology
SN - 0269-8811
IS - 11
ER -