protocolSection identificationModule nctId: NCT06309472, orgStudyIdInfo id: NIHR302528, briefTitle: Trial of Mirtazapine for Depression in IBD, acronym: MDIBD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: King's College Hospital NHS Trust, collaborators name: Imperial College London, collaborators name: London North West Healthcare NHS Trust, collaborators name: Imperial College Healthcare NHS Trust, collaborators name: Guy's and St Thomas' NHS Foundation Trust, descriptionModule briefSummary: 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., conditionsModule conditions: Major Depressive Disorder, conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Mirtazapine and placebo manufactured to appear identical through over-encapsulation, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Mirtazapine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Recruitment feasibility, primaryOutcomes measure: Trial adherence, primaryOutcomes measure: Treatment adherence, primaryOutcomes measure: Study procedures acceptability and compliance, primaryOutcomes measure: Overall acceptability, secondaryOutcomes measure: Quick Inventory for Depressive Symptomatology-16 Questionnaire, secondaryOutcomes measure: Patient Health Questionnaire-9 questionnaire, secondaryOutcomes measure: Generalised Anxiety Disorder-7 questionnaire, secondaryOutcomes measure: Inflammatory Bowel Disease Control questionnaire, secondaryOutcomes measure: Inflammatory Bowel Disease Fatigue Assessment Scale, secondaryOutcomes measure: Chalder Fatigue Scale, secondaryOutcomes measure: Maudsley 3-item Visual Analogue Scale, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: 9-item Avoidant Restrictive Food Intake Disorder Screen, secondaryOutcomes measure: Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) Questionnaire, secondaryOutcomes measure: Inflammatory Bowel Disease Resource Use Questionnaire (IBD-RUQ) items on employment and healthcare contacts, secondaryOutcomes measure: Birmingham Irritable Bowel Syndrome Symptoms Questionnaire, secondaryOutcomes measure: Harvey Bradshaw Index (Crohn's disease patients only), secondaryOutcomes measure: Simple Clinical Colitis Activity Index (ulcerative colitis patients only), secondaryOutcomes measure: Dietary Screener Questionnaire, secondaryOutcomes measure: Concentration of faecal calprotectin, secondaryOutcomes measure: Concentration of serum high-sensitivity C-reactive protein, secondaryOutcomes measure: Concentration of serum interleukin-23, secondaryOutcomes measure: Concentration of serum interleukin-22, secondaryOutcomes measure: Concentration of serum granulocyte-macrophage colony-stimulating factor, secondaryOutcomes measure: Concentration of serum interleukin-5, secondaryOutcomes measure: Concentration of serum interleukin-13, secondaryOutcomes measure: Concentration of serum interleukin-17A, secondaryOutcomes measure: Concentration of serum tumor necrosis factor alpha, secondaryOutcomes measure: Concentration of serum interferon-gamma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 125 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False