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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will test whether it is feasible to conduct a clinical trial of mirtazapine (an antidepressant tablet) in patients who have both depression and inflammatory bowel disease (IBD). The study design 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. The investigators will recruit outpatients aged 18 or over with a diagnosis of any IBD attending gastroenterology clinics. Either in person or remotely, patients will complete a brief screening questionnaire for depression. Those scoring positive for depression will be invited for a 15-minute interview for clinical depression. Those with clinical depression will be invited to take part. Participants will be randomly allocated by a computer to take either 1) mirtazapine tablet once at night for 12 weeks; or 2) placebo (dummy) tablet once at night for 12 weeks. The study is 'blinded', meaning neither patients nor the study team will know which medication they are taking. Throughout, participants will be able to access other treatments for depression, such as talking therapies. The investigators will measure how many people join the study; how many remain in the trial; how many complete treatment; how many tablets people take; and assess overall acceptability of the trial. Participants will complete brief questionnaires to measure their mental health and IBD symptoms after 4 weeks, 8 weeks, 12 weeks and 16 weeks. Participants will also provide blood samples and faecal samples to measure inflammation. If successful, this trial will support an application for a larger version of the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 125
Healthy Volunteers: f
View:

• Established diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) according to clinical notes

• Fulfil Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5) criteria for current single or recurrent episodes of major depressive disorder of at least moderate severity but without psychotic features, as defined by the Mini Neuropsychiatric Interview

• Aged 18 years or over

• Use of contraception if female and of childbearing age. Female participants of childbearing age will require a negative serum/urine pregnancy test before starting the study and will also need to agree to use an acceptable form of contraception throughout the intervention period, e.g. oral contraceptive pill, long-acting reversible contraceptive

• Able to provide written informed consent to enter the trial

Locations
Other Locations
United Kingdom
Guy's and St Thomas' Hospital NHS Foundation Trust
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
King's College Hospital NHS Foundation Trust
RECRUITING
London
St Mark's Hospital
RECRUITING
London
Contact Information
Primary
Calum D Moulton, PhD
calum.moulton@kcl.ac.uk
+44 (0) 20 7848 0088
Backup
Allan H Young, PhD
allan.young@kcl.ac.uk
+44 (0) 20 7848 0088
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 76
Treatments
Experimental: Mirtazapine
Mirtazapine 30-45mg at night for 12 weeks
Placebo_comparator: Placebo
Matched placebo 1-2 capsules at night for 12 weeks
Related Therapeutic Areas
Sponsors
Collaborators: London North West Healthcare NHS Trust, King's College Hospital NHS Trust, Imperial College Healthcare NHS Trust, Imperial College London, Guy's and St Thomas' NHS Foundation Trust
Leads: King's College London

This content was sourced from clinicaltrials.gov

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