Abstract
BackgroundInflammation contributes to the pathophysiology of major depressive disorder (MDD), and anti-inflammatory strategies might therefore have therapeutic potential. This trial aimed to determine whether adjunctive aspirin or rosuvastatin, compared with placebo, reduced depressive symptoms in young people (15–25 years).MethodsYoDA-A, Youth Depression Alleviation with Anti-inflammatory Agents, was a 12-week triple-blind, randomised, controlled trial. Participants were young people (aged 15–25 years) with moderate to severe MDD (MADRS mean at baseline 32.5 ± 6.0; N = 130; age 20.2 ± 2.6; 60% female), recruited between June 2013 and June 2017 across six sites in Victoria, Australia. In addition to treatment as usual, participants were randomised to receive aspirin (n = 40), rosuvastatin (n = 48), or placebo (n = 42), with assessments at baseline and weeks 4, 8, 12, and 26. The primary outcome was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 12.ResultsAt the a priori primary endpoint of MADRS differential change from baseline at week 12, there was no significant difference between aspirin and placebo (1.9, 95% CI (− 2.8, 6.6), p = 0.433), or rosuvastatin and placebo (− 4.2, 95% CI (− 9.1, 0.6), p = 0.089). For rosuvastatin, secondary outcomes on self-rated depression and global impression, quality of life, functioning, and mania were not significantly different from placebo. Aspirin was inferior to placebo on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) at week 12. Statins were superior to aspirin on the MADRS, the Clinical Global Impressions Severity Scale (CGI-S), and the Negative Problem Orientation Questionnaire scale (NPOQ) at week 12.ConclusionsThe addition of either aspirin or rosuvastatin did not to confer any beneficial effect over and above routine treatment for depression in young people. Exploratory comparisons of secondary outcomes provide limited support for a potential therapeutic role for adjunctive rosuvastatin, but not for aspirin, in youth depression.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12613000112763. Registered on 30/01/2013.
Highlights
Inflammation contributes to the pathophysiology of major depressive disorder (MDD), and antiinflammatory strategies might have therapeutic potential
A total of 1263 potential participants were considered for eligibility for the trial, of which 130 were randomised to receive aspirin (n = 40), rosuvastatin (n = 48), or placebo (n = 42)
Together with higher use of concomitant medication in the placebo group, these findings provide a tentative suggestion for potential utility of statins, but indicate a lack of efficacy of low dose aspirin
Summary
Inflammation contributes to the pathophysiology of major depressive disorder (MDD), and antiinflammatory strategies might have therapeutic potential. This trial aimed to determine whether adjunctive aspirin or rosuvastatin, compared with placebo, reduced depressive symptoms in young people (15–25 years). The peak period for depression onset is youth and early adulthood It has deleterious social, educational, and developmental effects [3, 4], and can lead to recurrent major illness episodes [5, 6]. Educational, and developmental effects [3, 4], and can lead to recurrent major illness episodes [5, 6] It is uncertain if antidepressants are effective in youth depression, with the possible exception of fluoxetine [7, 8]. There is a clear need for the development of effective adjunctive interventions that might be acceptable to young people experiencing depression [13]
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