Plain-English translation of NCT06309472 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Major Depressive Disorder research guide →Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This feasibility study is testing whether , an antidepressant, can help treat depression in people who have inflammatory bowel disease (IBD). Half of participants will receive the active medication while the other half receive a placebo (inactive pill), and both groups will continue their regular IBD treatments. The study will run for 12 weeks to see if this medication is safe, acceptable, and worth studying more deeply.
Depression is very common in people with IBD and makes their bowel disease harder to manage, but there hasn't been solid research yet on whether this medication—which is less likely to cause digestive side effects than other antidepressants—might help this specific patient group.
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If you join this study, you will randomly be assigned to take either the active medication or a placebo pill at night for 12 weeks. You will have study visits at the start, then at 4 weeks, 8 weeks, and 12 weeks to answer questions about your depression and overall health. After the 12 weeks of treatment, you will gradually reduce the dose over 2–3 weeks, with one final follow-up visit at 16 weeks to check how you are doing.
AI-generated summary from trial data · Jun 11, 2026 · Not medical advice
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