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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Calum
Moulton
calum.moulton@kcl.ac.uk
Dr
Calum
Moulton
calum.moulton@kcl.ac.uk
Mr
Johura
Akther-Robertson
Johura.aktherrobertson1@gstt.nhs.uk
Noninfective enteritis and colitisMood [affective] disorders
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
1) Diagnosis of drug or alcohol dependence syndrome according to patient report or GP record. 2) Diagnosis of any personality disorder according to patient report or GP record. 3) Diagnosis of any dementia according to patient report or GP record. 4) Diagnosis of psychosis or schizophrenia according to patient report or GP record. 5) Diagnosis of bipolar disorder according to patient report or GP record. 6) Current active suicidal ideation on clinical assessment by study psychiatrist. 7) Current treatment with mirtazapine, mianserin, trazodone or a monoamine oxidase inhibitor. 8) Contraindications to the administration of mirtazapine, as per the current SmPC. 9) Patient-reported hypersensitivity to mirtazapine or mianserin. 10) Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held. 11) Currently enrolled in another drug trial or psychological therapy trial. 12) Currently hospitalised for the treatment of IBD. 13) Currently being prescribed a course of budesonide or reducing course of prednisolone for IBD. 14) Planned change in IBD treatment within the next 12 weeks.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Calum
Moulton
calum.moulton@kcl.ac.uk
Mr
Johura
Akther-Robertson
Johura.aktherrobertson1@gstt.nhs.uk
Dr
Calum
Moulton
calum.moulton@kcl.ac.uk
The study is sponsored by King's College London and funded by NIHR Academy .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 57933
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
