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RECRUITING
NCT06309472
PHASE2

Trial of Mirtazapine for Depression in IBD

Sponsor: King's College London

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 125 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2024-05-01

Completion Date

2026-10

Last Updated

2024-08-22

Healthy Volunteers

No

Interventions

DRUG

Mirtazapine

30mg mirtazapine at night, escalated to 45mg after 4 weeks if \<20 percent improvement in depression from baseline. Total treatment duration 12 weeks.

DRUG

Placebo

1 placebo capsule at night, escalated to 2 capsules after 4 weeks if \<20 percent improvement in depression from baseline. Total treatment duration 12 weeks.

Locations (4)

Guy's and St Thomas' Hospital NHS Foundation Trust

London, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

St Mark's Hospital

London, United Kingdom