RecruitingPHASE2INTERVENTIONAL

Trial of Mirtazapine for Depression in IBD

This study is a first step to see if a tablet called mirtazapine could help people who have both depression and a bowel condition (Inflammatory Bowel Disease, or IBD). Currently, mirtazapine hasn't been specifically tested for this group. Researchers want to find out if it's practical to run a bigger study on this topic. They'll compare mirtazapine to a dummy pill (placebo) in 76 patients. The study will check things like how many people join, stay in the study, and take their tablets, as well as if they find it acceptable. If this initial study goes well, it could lead to a larger, more detailed trial to truly see if mirtazapine is an effective treatment for depression in people with IBD.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

King's College London

Enrolment target

Start

01 May 2024

Estimated completion

01 Oct 2026

Major Depressive Disorder Inflammatory Bowel Diseases

What is this study about?

Depression is quite common in people who have Inflammatory Bowel Disease (IBD), and it can make their IBD symptoms worse. There's a particular tablet for depression called mirtazapine that seems promising for people with IBD. This is because it doesn't affect how the gut moves very much, can help with feeling sick, is well absorbed by the body, and has a low chance of causing certain side effects often linked to other depression medications. However, it’s never been formally tested in people who have both depression and IBD.

This study, called a 'feasibility study', is essentially a trial run. The main goal is to find out if it's practical and possible to carry out a larger study comparing mirtazapine with a dummy pill (placebo) for depression in people with IBD. This means researchers will be looking at things like how easy or difficult it is to find people to take part, how many people stay in the study, how happy they are with the study, and whether the way they collect information works well. They want to make sure everything is in place before thinking about a much bigger study that would definitively tell us if mirtazapine is an effective treatment.

If this smaller study goes well, it will provide the information needed to design and apply for a bigger version. Ultimately, the hope is to find better ways to help people living with both depression and IBD to feel better and improve their overall health.

Key takeaways

This is a study to see if a larger trial of mirtazapine for depression in IBD is possible.
It involves comparing the depression tablet mirtazapine with a dummy pill (placebo).
Neither you nor the study team will know which tablet you are taking.
Participation lasts about 16 weeks, including 12 weeks of taking tablets.
You can still have other depression treatments like talking therapies during the study.
Results from this study will help decide if a full-scale trial should be done.

Who may be eligible?

To be able to take part in this study, you would need to be 18 years or older and have a confirmed diagnosis of certain types of IBD (Crohn's disease or ulcerative colitis), which will be checked in your medical records. You would also need to be experiencing a certain level of depression that meets specific medical criteria, as identified through a short screening questionnaire and a 15-minute interview.

There are also some important reasons why you might not be able to join. For example, if you have a history of drug or alcohol dependence, certain personality disorders, dementia, psychosis, schizophrenia, or bipolar disorder, you wouldn't be able to take part. If you're currently having thoughts of harming yourself, or if you're already taking certain other depression medications (like mirtazapine, mianserin, trazodone, or a monoamine oxidase inhibitor), this study wouldn't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Crohn's disease or ulcerative colitis (IBD)?
Are you currently experiencing symptoms of depression?
Have you been diagnosed with any mental health conditions other than depression (like bipolar disorder or psychosis)? (If yes, you might not be eligible.)
Are you currently taking mirtazapine or certain other specific depression medications?
Are you able to provide written agreement to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first complete a short questionnaire to check for depression. If this suggests you might have depression, you'll have a 15-minute interview to confirm this. If you meet the criteria for depression and are eligible, you'll be invited to join. A computer will then randomly decide whether you receive the mirtazapine tablet or a dummy tablet (placebo) – it’s like flipping a coin, so neither you nor the study team will know which you are taking. You’ll take one tablet each night for 12 weeks.

During these 12 weeks, you'll also complete short questionnaires about your mental health and IBD symptoms at weeks 4, 8, and 12. You'll also be asked to provide some blood and stool samples to check for inflammation. After you finish taking the tablets for 12 weeks, you’ll have a final follow-up at 16 weeks, which will involve another short questionnaire. The entire process, from starting the tablets to the final follow-up, will last about 16 weeks. Throughout the study, you'll still be able to access other treatments for depression, such as talking therapies.

Potential risks and benefits

This study is designed to see if a larger trial is possible, and it's not yet known if mirtazapine will improve depression in people with IBD. Potential benefits might include closer monitoring of your depression and IBD symptoms. However, like all medications, mirtazapine can have side effects, and your doctor can discuss these with you. Taking a dummy pill naturally means you won't experience the effects of mirtazapine, but you'll still be monitored. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Guy's and St Thomas' Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting
King's College Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
St Mark's Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a 'dummy tablet' (placebo)?

A dummy tablet looks just like the real medication but doesn't contain any active ingredients. It's used to compare the real drug's effects.

Why don't I know if I'm getting the real tablet or the dummy one?

This is called a 'blinded' study. It helps ensure that any results are due to the tablet itself, not because people expect to feel better or worse from one treatment or the other.

Can I still see my therapist if I join the study?

Yes, you can continue to access other treatments for depression, such as talking therapies, if you are part of this study.

What happens if the study goes well?

If this initial study goes well, it will mean researchers have enough information to design and potentially get funding for a much larger study to confirm if mirtazapine is an effective treatment for depression in people with IBD.

Will taking part affect my regular IBD treatment?

The study aims to see if mirtazapine helps *in addition* to your usual treatments. Please discuss any concerns about your regular treatment with your doctor.

How to find out more

Calum D Moulton, PhD

calum.moulton@kcl.ac.uk +44 (0) 20 7848 0088 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.