The Insight Study: A randomised controlled trial of single-dose tocilizumab in patients with depression and low-grade inflammation.

Éimear M Foley, Joel Parkinson, Bianca Oltean, Golam Khandaker

Research output: Contribution to conferenceConference Abstract

Abstract

Aims
Pharmacotherapy for depression is predicated on monoamine neurotransmitters, but other mechanisms are likely to be involved. Observational studies indicate potentially causal role for interleukin 6 (IL-6), a pro-inflammatory cytokine, in pathogenesis of depression, but interventional studies based on depressed patients have not yet been conducted. Tocilizumab is a humanised monoclonal antibody that inhibits IL-6 receptor signalling and is licensed in the UK for treatment of rheumatoid arthritis. The Insight study aims to test whether IL-6 contributes to pathogenesis of depression and to determine its potential as a treatment target.

Methods
Proof-of-concept, randomised, parallel-group, double-blind, placebo-controlled clinical trial involving 50 participants with International Classification of Diseases 10th revision (ICD-10) diagnosis of depression and evidence of low-grade inflammation (defined as serum high-sensitivity C-reactive protein level ≥3 mg/L) randomised to a single intravenous infusion of either tocilizumab or normal saline. Mood, cognition and blood-based immunological measures assessed at baseline and 7, 14 and 28 days after infusion. The primary outcome is depression somatic symptoms score approximately 14 days post-infusion.

Results
To date, 24 patients have been recruited and treated with tocilizumab/placebo; mean age 40.32 years (SD=12.37), 20 (83.33%) females, 21 (87.50%) white ethnicity. Based on data thus far, intravenous tocilizumab appears to be well tolerated by depressed patients. No severe adverse reactions were noted. Mild, brief, self-limiting influenza-like symptoms were noted for 3 participants.

Conclusions
Based on the data collected to date, intravenous tocilizumab treatment is feasible, well-tolerated and accepted by depressed patients. Side effect incidence is low.
Original languageEnglish
Publication statusUnpublished - 2020
EventFederation of European Neuroscience Societies 2020 Virtual Forum -
Duration: 11 Jul 202015 Jul 2020

Conference

ConferenceFederation of European Neuroscience Societies 2020 Virtual Forum
Abbreviated titleFENS 2020 Virtual Forum
Period11/07/2015/07/20

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