Feasibility trial of mirtazapine for depression in IBD
Research type
Research Study
Full title
A multi-centre, double-blind randomised controlled trial to compare Mirtazapine versus placebo over 12 weeks in patients with multimorbid major depression and Inflammatory Bowel Disease (MD-IBD): a feasibility study
IRAS ID
326041
Contact name
Calum Moulton
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 3 months, 2 days
Research summary
Around 20% of people with inflammatory bowel disease (IBD) have depression. Compared to people with IBD without depression, those with depression have worse quality of life, worse IBD symptoms and more often need bowel-removing surgery. However, there has been no trial of any UK-licensed antidepressant in patients with both clinical depression and IBD.
The current study is a randomised controlled trial (a study in which people are allocated by chance to receive different interventions). The trial will compare mirtazapine against a placebo (dummy) tablet in 76 patients with both depression and IBD. This is a feasibility study, meaning it is testing whether it will be possible to do a larger version of this study.
We will recruit outpatients aged 18 or over with a diagnosis of IBD attending gastroenterology clinics at 4 London hospitals. Those with clinical depression according to brief interview will be invited to take part.
Participants will be randomly allocated by a computer to take either 1) mirtazapine tablet once at night; or 2) placebo (dummy) tablet once at night for 12 weeks. The study is ‘blinded’, meaning neither patients nor the study team know which medication they are taking. After 12 weeks, people will be able to continue mirtazapine through their GP. Throughout, participants can access talking therapies for depression if needed.
We will examine the number of patients we recruit, the number who stop the treatment, and the acceptability of the trial to patients. Participants will complete a range of questionnaires that we would plan to use in a larger study. We will measure the completeness of the questionnaire data. We will also test the feasibility of taking blood tests and a faecal (poo) measure of IBD activity.
If this study is feasible, we will use it to inform a future large (powered) version of this study.
REC name
London - Queen Square Research Ethics Committee
REC reference
23/LO/0709
Date of REC Opinion
29 Oct 2023
REC opinion
Further Information Favourable Opinion