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Inflammatory Bowel Diseases / Mirtazapine / Major Depressive Disorder · Phase 2 Trial
ClinicalTrials.gov · August 19, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 2 feasibility and safety trial of mirtazapine versus placebo in patients with comorbid major depression and inflammatory bowel disease. No results are posted in this registry record; the study aims to assess recruitment, retention, adherence, and acceptability to inform design of a larger trial.
Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Major Depressive Disorder, Inflammatory Bowel Diseases; age from 18 Years; to 125 Years. Intervention: Mirtazapine. Compared with: Placebo — Placebo Comparator. n = 76. 4 sites: United Kingdom.
This is a registered Phase 2 feasibility and safety trial of mirtazapine versus placebo in patients with comorbid major depression and inflammatory bowel disease. No results are posted in this registry record; the study aims to assess recruitment, retention, adherence, and acceptability to inform design of a larger trial.
No efficacy or safety results reported; this is a registry record of a completed recruitment, not an outcomes report.
This registry entry does not provide results and therefore does not support clinical decisions. It identifies a planned feasibility trial; readers should await published results to learn whether mirtazapine can be tested effectively in this population.
A Phase 2 feasibility trial with no results reported; designed to assess recruitment and trial conduct in a specific population, not to evaluate efficacy.
As stated by the source record.
Quoted from the source exactly as published.
This registry entry does not provide results and therefore does not support clinical decisions. It identifies a planned feasibility trial; readers should await published results to learn whether mirtazapine can be tested effectively in this population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06309472). This is a study registration, not published results. Lead sponsor: King's College London. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 76 participants (ACTUAL). Conditions: Major Depressive Disorder, Inflammatory Bowel Diseases. Interventions: DRUG: Mirtazapine; DRUG: Placebo. Primary outcome measures: Recruitment feasibility , Up to 2 years; Trial adherence , 12 weeks; Treatment adherence , 12 weeks; Study procedures acceptability and compliance , 12 weeks; Overall acceptability , 12 weeks. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.