Background: Not only is depression associated with increased inflammation but inflammation is a risk factor for the genesis of depression. Many of the environmental risk factors for depression are transduced through inflammatory signaling. Anti-inflammatory agents show promise for the management of depression in preclinical, epidemiological, and early clinical studies. This opens the door to the potential for anti-inflammatory agents to treat and prevent depression. There are no evidence-based pharmacotherapies for depression prevention. Method: ASPREE-D, aspirin in the prevention of depression in the elderly, is a sub study of ASPREE, which explores the potential of aspirin to prevent a range of inflammation related disorders in the elderly. With a sample size of 19,114, and a duration of 5 years, this placebo controlled study will be one of the largest randomized controlled trials in psychiatry and will provide definitive evidence on the ability of aspirin to prevent depression. Results: This paper presents the rationale for the study and presents a summary of the study design. Conclusions: ASPREE-D may not only define novel therapy but will provide mechanistic proof of concept of the role of inflammation in depression.
Bibliographical noteFunding Information:
The ASPREE-D study is funded by a project grant from the NHMRC (1081901). The ASPREE principal study which recruited participants and is responsible for all follow-up measurements including clinical endpoints, SF-12 and other data capture is funded primarily by a grant from the US National Institute on Aging (1R01AG029824- 01A2) with additional support from Australia's NHMRC (ID334047), the Victorian Cancer Agency and Monash University. The ASPREE Healthy Ageing Biobank, which collected the blood samples for measures of inflammatory biomarkers for this study, was funded by a Flagship Cluster Collaboration award from the CSIRO and from the National Cancer Institute through a supplement (5U01AG029824- 02 (ASPREE 07210)) to the NIH ASPREE grant. ASPREE is registered on the International Standard Randomized Controlled Trial Number Register (ISRCTN83772183). Bayer Pharma AG provides blinded aspirin and placebo. ASPREE has multiple IRB approvals in the US and Australia. MB is supported by a NHMRC Senior Principal Research Fellowship 1059660. AMM receives research support from the National Institutes of Health. CMR receives research support from the NHMRC (Program grant 1092642) and the Heart Foundation and is supported by a NHMRC Senior Research Fellowship (1045862).