The Insight Study
Research type
Research Study
Full title
IL-6 Inhibition in Patients with Depression and Low-grade Inflammation: The Insight Study
IRAS ID
238297
Contact name
Golam Khandaker
Contact email
Sponsor organisation
Cambridgeshire and Peterborough NHS Foundation Trust and The University of Cambridge
ISRCTN Number
ISRCTN16942542
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Objectives:
Research suggests inflammation may cause depression, but precise mechanisms are unknown. The main objectives of this study are to test whether interleukin 6 (IL-6), a pro-inflammatory protein, contributes to pathogenesis of depression, and to examine potential mechanisms by which IL-6 affects mood and cognition. A secondary objective is to compare depressed participants with and without evidence of low-grade systemic inflammation.
Study Design:
We propose a proof-of-concept, randomized, double blind, placebo-controlled experiment based on approximately 50 depressed participants (intervention cohort) who have evidence of low-grade inflammation (i.e., serum/plasma high sensitivity C-reactive protein (hsCRP) level ≥3mg/L). Participants will be randomized into two groups to receive single intravenous infusion of normal saline (placebo) or tocilizumab (a drug that inhibits IL-6 signalling and is licensed in the UK for treatment of rheumatoid arthritis). Behavioural and cognitive measures and blood samples will be collected at baseline and after infusion around day 7, 14 and 28. Approximately 50 depressed participants without low-grade inflammation (serum/plasma hsCRP level <3mg/L) will complete the same baseline assessments as the intervention cohort allowing us to fulfil the secondary objective.
Study Population:
With support from the Clinical Research Network, identification and recruitment of participants will be carried out from primary care and mental health services in Cambridgeshire, Suffolk and Norfolk. Eligible participants will be aged 20-65 years, meet ICD-10 criteria for diagnosis of depression and other inclusion/exclusion criteria.
Outcomes:
The primary outcome will be change in somatic symptoms of depression in the tocilizumab group compared with placebo at follow-up. Secondary outcomes will include depression severity, cognitive function, and blood-based biomarkers.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0118
Date of REC Opinion
17 Apr 2018
REC opinion
Further Information Favourable Opinion