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Can an antidepressant soothe both mind and gut?

NCT ID NCT06309472

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial explores whether it is possible to run a larger study of mirtazapine, an antidepressant, in people who have both major depression and inflammatory bowel disease (IBD). About 76 adults with IBD and depression will be randomly assigned to take either mirtazapine or a placebo tablet every night for 12 weeks. The study is 'blinded', so neither participants nor researchers know who gets which treatment. The main goal is to see if people will join, stay in, and complete the trial, and whether the treatment is acceptable. If successful, this could pave the way for a bigger study to see if mirtazapine helps both depression and IBD symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mirtazapine (an antidepressant tablet, also known as Remeron)
What this could lead to
If this trial shows it is feasible, it could lead to a larger study testing whether mirtazapine can ease depression in people with IBD, potentially improving both mental and gut health.
What could go wrong
This is a small feasibility study, not a proof of effectiveness. It may not show clear benefits, and mirtazapine can have side effects like drowsiness and weight gain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

76 people

The number who actually took part.

Started

May 2024

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 125 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.