CNTO136 sirukumab
Research type
Research Study
Full title
A double-blind, placebo-controlled, multicentre study of sirukumab as adjunctive treatment to a monoaminergic antidepressant in adults with major depressive disorder
IRAS ID
203002
Contact name
Nagore Penades
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2014-005206-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
This is a double-blind, placebo-controlled, multicentre study in adults with major depressive disorder (MDD), who have not had the best response to standard oral antidepressant therapy and who have failed no more than three antidepressant treatments in the current major depressive episode.
Most sufferers of MDD, which many know as a mental disorder, suffer from low mood. MDD is currently treated with oral antidepressant therapy (known as the monoaminergic antidepressants) but there is a significant subset of patients who experience minimal response to these treatments. There are many causes of MDD, and it is thought that around one third of these patients also suffer from inflammation, which may be a cause.
Sirukumab is a new treatment being studied for MDD that may help to reduce depression from the initial study visit as compared to placebo when administered additional to standard therapy. Sirukumab binds to human interleukin-6 (IL-6) and stops it working. IL-6 is a cytokine, meaning that it is a substance created by certain cells in the immune system, and effects other cells. In the case of IL-6, the effect is inflammation, and research has shown that IL-6 is higher in patients with clinical depression. Therefore, if inflammation is a cause of MDD, by focusing on IL-6, sirukumab may reduce depression.
In this study, approximately 192 participants will be enrolled into one of two arms. Approximately 96 participants will receive sirukumab, and approximately 96 participants will receive placebo (both administered as a 50mg injection at day 1, day 28 and day 56), both in addition to standard antidepressant therapy.
The study will be divided into three sections: a screening period of up to 4 weeks, a treatment period of 12 weeks, and a follow up period of 14 weeks.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1086
Date of REC Opinion
9 Aug 2016
REC opinion
Further Information Favourable Opinion