Trial of Mirtazapine for Depression in IBD

NCT06309472 | Recruiting Phase 2

• 1 other identifier: NIHR302528
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Major Depressive Disorder; Inflammatory Bowel Diseases

Keywords

Mirtazapine; Placebo; Depression; Randomised controlled trial; Feasibility trial; Inflammatory bowel disease; Crohn's disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (5)

• Recruitment feasibility

  Participants randomised overall, percentage of target

  Up to 2 years

• Trial adherence

  Percentage of participants completing 12 weeks of treatment

  12 weeks

• Treatment adherence

  Percentage of participants taking at least 75% of prescribed mediation

  12 weeks

• Study procedures acceptability and compliance

  Percentage of planned data and samples collected at primary endpoint (12 weeks)

  12 weeks

• Overall acceptability

  Percentage of participants describing the treatment as acceptable (≥6/10 on 0-10 scale)

  12 weeks

Secondary Outcomes (25)

• Quick Inventory for Depressive Symptomatology-16 Questionnaire

  Baseline, 4, 8, 12 and 16 weeks

• Patient Health Questionnaire-9 questionnaire

  Baseline, 4, 8, 12 and 16 weeks

• Generalised Anxiety Disorder-7 questionnaire

  Baseline, 4, 8, 12 and 16 weeks

• Inflammatory Bowel Disease Control questionnaire

  Baseline, 4, 8, 12 and 16 weeks

• Inflammatory Bowel Disease Fatigue Assessment Scale

  Baseline, 4, 8, 12 and 16 weeks

Study Arms (2)

Mirtazapine

EXPERIMENTAL

Mirtazapine 30-45mg at night for 12 weeks

Drug: Mirtazapine

Placebo

PLACEBO COMPARATOR

Matched placebo 1-2 capsules at night for 12 weeks

Drug: Placebo

Interventions

Mirtazapine DRUG

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

Also known as: Remeron

Mirtazapine

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) according to clinical notes
• 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
• Aged 18 years or over
• 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
• Able to provide written informed consent to enter the trial

You may not qualify if:

• 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?"
• 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?"
• 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?"
• 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?"
• 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?"
• Current active suicidal ideation on clinical assessment according to clinical judgment by a study consultant psychiatrist
• Current treatment with mirtazapine, mianserin, trazodone or a monoamine oxidase inhibitor
• Contraindications to the administration of mirtazapine, as per the current summary of product characteristics
• Known allergy to mirtazapine or mianserin according to patient report or clinical notes
• Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held
• Currently enrolled in another drug trial or psychological therapy trial
• Currently hospitalised for the treatment of IBD
• Currently being prescribed a course of budesonide or reducing course of prednisolone for IBD
• 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?"

Sponsors & Collaborators

• King's College London: lead
• King's College Hospital NHS Trust: collaborator
• Imperial College London: collaborator
• London North West Healthcare NHS Trust: collaborator
• Imperial College Healthcare NHS Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (4)

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

MeSH Terms

Conditions

Depressive Disorder, Major; Inflammatory Bowel Diseases; Depression; Crohn Disease; Colitis, Ulcerative

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavioral Symptoms; Behavior; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Calum D Moulton, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calum D Moulton, PhD

CONTACT

+44 (0) 20 7848 0088; calum.moulton@kcl.ac.uk

Allan H Young, PhD

CONTACT

+44 (0) 20 7848 0088; allan.young@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Mirtazapine and placebo manufactured to appear identical through over-encapsulation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 13, 2024
• Study Start: May 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)