The Insight Study
Study now closed for recruitment
A proof-of-concept, randomised, double blind, placebo controlled study of the effect of
anti-inflammation treatment in individuals with depression.
What is this study about?
Research suggests that low-grade inflammation (i.e. overactivity of one aspect of the immune system, which can be measured by a blood test) may play a role in the development and persistence of depressive symptoms. This study aims to investigate whether reducing inflammation with an anti-inflammatory drug (tocilizumab) can help reduce symptoms of depression.
Why are we doing this study?
Depression causes suffering to millions of people worldwide and approximately 1/3 of depressed patients do not respond to antidepressants. A third of depressed patients also show evidence of low-grade systemic inflammation – this is unlikely to be a coincidence. The Insight Study will give us more insight into whether inflammation plays a role in causing depression and if anti-inflammatory drugs may be used for treating some patients with depression in future.
Who are we looking for?
We are looking for individuals who meet the following criteria:
-
Aged 20-55 years.
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Currently depressed.
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Currently taking an anti-depressant.
Participants additionally must have
no
history of infection or antibiotic treatment in the last 4 weeks at the time of taking part and have
no
current or previous diagnosis of bipolar disorder, psychotic disorder, or personality disorder.
What would be involved?
If you indicate that you are willing to participate and you are deemed potentially eligible, you will be invited to attend an assessment to confirm your eligibility. Here, you will complete a few questionnaires and will be asked to provide a blood sample.
Eligible participants will take part in 5 further meetings: baseline assessment, infusion, follow-up 1, follow-up 2, and follow-up 3. Each participant will receive one intravenous infusion of either tocilizumab or a placebo (saline). These meetings will also involve a number of questionnaires, physical measurements, and blood samples.
Tocilizumab is licenced and used in the NHS for treatment of juvenile idiopathic and rheumatoid arthritis.
Participants are reimbursed for travel expenses and their time.
Further information on the Insight Study can be found in our
Participant Information Sheet
.
If you would like to discuss this study with a researcher please click the logo below.