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

NIHR302528

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.

2024-03-01

2026-02-01

2026-06-01

Not yet recruiting

Early phase I

76

Inclusion Criteria: 1. Established diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) according to clinical notes 2. 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 3. Aged 18 years or over 4. 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 5. Able to provide written informed consent to enter the trial Exclusion Criteria: 1. Diagnosis of drug or alcohol dependence syndrome according to the General Practitioner (GP) summary care record or yes in answer to the question "have you ever been diagnosed with drug or alcohol dependence?" 2. Diagnosis of any personality disorder according to the GP summary care record or yes in answer to the question "have you ever been diagnosed with a personality disorder?" 3. Diagnosis of any dementia according to the GP summary care record or yes in answer to the question "have you ever been diagnosed with any form of dementia?" 4. Diagnosis of psychosis or schizophrenia according to the GP summary care record or yes in answer to the question "have you ever been diagnosed with psychosis or schizophrenia?" 5. Diagnosis of bipolar disorder according to the GP summary care record or yes in answer to the question "have you ever been diagnosed with bipolar disorder?" 6. Current active suicidal ideation on clinical assessment according to clinical judgment by a study consultant psychiatrist 7. Current treatment with mirtazapine, mianserin, trazodone or a monoamine oxidase inhibitor 8. Contraindications to the administration of mirtazapine, as per the current summary of product characteristics 9. Known allergy to mirtazapine or mianserin according to patient report or clinical notes 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 according to clinical notes or answer yes to the question: "are you expecting any change in your IBD treatment to take place in the next 12 weeks?"

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2024-03-13