drugset / Trial / NCT07431606
Duloxetine in Inflammatory Bowel Diseases
NaSingle-groupOpen-labelTreatment
Summary
This open-label, prospective, single-arm pilot study investigates the use of duloxetine, a central neuromodulator, for improving psychological distress and functional impairment in adults with inflammatory bowel disease (IBD). The study focuses on patient-reported outcomes related to anxiety, depression, and IBD-related disability, aiming to assess feasibility, tolerability, and preliminary efficacy in modulating gut-brain axis symptoms and disease-related functional impairments in life
Timeline
- Start
- 2026-05-01
- Primary completion
- 2027-03-01
- Completion
- 2027-10-31
Publications
- Results Birkinshaw H, Friedrich CM, Cole P, Eccleston C, Serfaty M, Stewart G, White S, Moore RA, Phillippo D, Pincus T. Antidepressants for pain management in adults with chronic pain: a network meta-analysis. Cochrane Database Syst Rev. 2023 May 10;5(5):CD014682. doi: 10.1002/14651858.CD014682.pub2.
- Results Khasawneh M, Mokhtare M, Moayyedi P, Black CJ, Ford AC. Efficacy of gut-brain neuromodulators in irritable bowel syndrome: an updated systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2025 Jun;10(6):537-549. doi: 10.1016/S2468-1253(25)00051-2. Epub 2025 Apr 18.
- Results Daghaghzadeh H, Naji F, Afshar H, Sharbafchi MR, Feizi A, Maroufi M, Tabatabaeeyan M, Adibi P, Tavakoli H. Efficacy of duloxetine add on in treatment of inflammatory bowel disease patients: A double-blind controlled study. J Res Med Sci. 2015 Jun;20(6):595-601. doi: 10.4103/1735-1995.165969.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 30 mg | Oral |
| Subject | Duloxetine | Small molecule | 60 mg | Oral |