ASPIRE: Advanced stratification of people with depression based on Inflammation

There is a high risk that the mental health field is foregoing the opportunity to use anti-inflammatory medications in depression, because of the lack of studies that target the right people by stratifying them based on inflammatory markers. This study, co-designed with people with lived experience (PWLE) of depression, will: (1) Identify, in existing clinical trials of anti-inflammatories in major depressive disorder (MDD), a set of hypothesis-driven, inflammation-related, clinical, blood, and neuroimaging stratification markers that accurately predict depression response; (2) Use machine-learning to generate a decision tool that identifies depressed people who will respond to anti-inflammatories medications and thus could access these drugs as early intervention; (3) Assess the feasibility and acceptability of the tool in a proof-of-concept, open-labelled, stratified prospective study, delivered in Europe, the USA and South Africa; (4) Explore PWLE’s views regarding the role of inflammation in depression; and (5) Produce scientific publications, conference presentations and public engagement outputs (blogs, podcasts, social media campaigns) describing the outcomes and impact of the study. Our study, bringing together n=10 existing trials led by PIs/collaborators (n>1200 people with depression) and n=250 newly recruited individuals, will lead to innovative personalized treatments and early interventions for depression according to patients’ stratification markers.