Testing Mirtazapine for Depression in Patients with Inflammatory Bowel Disease
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
This study is testing if the antidepressant mirtazapine can help people with depression who also have inflammatory bowel disease feel better over 12 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 125 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 4 sites (London and 3 other locations) |
| Trial ID | NCT06309472 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the feasibility of using mirtazapine, an antidepressant, in patients suffering from both major depressive disorder and inflammatory bowel disease (IBD). The study will randomly assign 76 participants to receive either mirtazapine or a placebo for 12 weeks, alongside their usual treatment. Researchers will evaluate recruitment, retention, and adherence rates, as well as the acceptability of the treatment through qualitative interviews. The findings will help inform the design of a larger, definitive trial in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with a diagnosis of Crohn's disease or ulcerative colitis who also meet the criteria for major depressive disorder.
Not a fit: Patients with drug or alcohol dependence syndrome or those without a diagnosis of IBD will not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide an effective treatment option for patients with depression and IBD, potentially improving their overall quality of life.
How similar studies have performed: While mirtazapine has not been previously tested in IBD patients, other studies have shown antidepressants can be beneficial in similar populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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?"
Where this trial is running
London and 3 other locations
- Guy's and St Thomas' Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
- St Mark's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Calum D Moulton, PhD — King's College London
- Study coordinator: Calum D Moulton, PhD
- Email: calum.moulton@kcl.ac.uk
- Phone: +44 (0) 20 7848 0088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.