Cure8 trial brief
Depression is common in people with IBD and can worsen quality of life and disease outcomes. This trial explores whether mirtazapine—an antidepressant thought to have favorable gastrointestinal tolerability—can be feasibly studied in this population and whether a larger definitive trial is possible.
Adults with Crohn's disease or ulcerative colitis who have depression; gastroenterology clinicians and mental-health providers working with IBD patients; researchers planning trials of psychiatric treatments in IBD.
This is a Phase 2 feasibility randomized, placebo-controlled trial testing mirtazapine versus placebo for depression in adults with IBD (Crohn's disease or ulcerative colitis). The blinded intervention lasts 12 weeks with follow-up to 16 weeks.
Outcomes focus on feasibility measures (recruitment, retention, adherence, acceptability) and collection of mental health and IBD symptom questionnaires plus blood and fecal samples for inflammation. This summary is based on the clinicaltrials.gov record (trial registration NCT06309472) and does not report trial results.
This record is a trial protocol/registry entry (Phase 2 feasibility RCT) and does not present efficacy or safety results. The primary aims are feasibility and study procedures rather than clinical outcomes. Participants can continue other depression treatments (e.g., talking therapies) alongside the blinded medication.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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