Key result
Adjunctive treatment with either rosuvastatin or aspirin did not significantly improve depressive symptoms compared to placebo in youth with moderate to severe major depressive disorder.
Why the study?
Because inflammation contributes to the pathophysiology of major depressive disorder, this trial evaluated whether adjunctive aspirin or rosuvastatin reduced depressive symptoms in young people.
Does adjunctive rosuvastatin or aspirin reduce depressive symptoms in young people with moderate to severe major depressive disorder?
RCT (n=130)
Triple-blind
1:1:1 ratio using randomly permuted blocks
Yes
Does adjunctive rosuvastatin or aspirin reduce depressive symptoms in young people with moderate to severe major depressive disorder?
The addition of aspirin or rosuvastatin to standard treatment did not significantly improve depressive symptoms in young people with moderate to severe major depressive disorder.
Answers are grounded in this paper and cite their sources.
Adjunctive rosuvastatin or aspirin should not be used in youth MDD; challenges anti-inflammatory adjunctive therapy hypothesis.
BACKGROUND: Inflammation 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). METHODS: YoDA-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. RESULTS: At 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. CONCLUSIONS: The 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 REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12613000112763. Registered on 30/01/2013.
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Berk et al. (2020) conducted an RCT in Major Depressive Disorder (n=130). Rosuvastatin or Aspirin vs. Placebo was evaluated on Change in MADRS score from baseline to week 12 (MD -4.2, 95% CI -9.1, 0.6, p=0.089). Adjunctive treatment with either rosuvastatin or aspirin did not significantly improve depressive symptoms compared to placebo in youth with moderate to severe major depressive disorder.
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