Duloxetine in Inflammatory Bowel Diseases

NCT07431606 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 859508
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Change in IBD-related disability

  IBD Disability Index scores, range 0-100, higher score indicates more disability

  6 weeks

Secondary Outcomes (3)

• Changes in psychological distress

  6 weeks

• Tolerability and safety

  6 weeks

• Changes in gastrointestinal-specific anxiety

  6 weeks

Study Arms (1)

Duloxetine

EXPERIMENTAL

Duloxetine 30-60 mg daily per oral

Drug: Duloxetine

Interventions

Duloxetine DRUG

antidepressant; central neuromodulator

Also known as: cymbalta

Duloxetine

Eligibility Criteria

• Age: 24 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 24 years old; (younger patients are excluded because antidepressants have been shown to increase the risk of suicidal thinking and behavior in patients ≤ 24 years old.)
• At least one of the following:
• elevated psychological distress (Distress Thermometer score \> 4),10-12
• moderate-to-severe IBD-related disability (IBD-DI score ≥ 356, 7), or
• elevated GI-specific anxiety (Visceral Sensitivity Index \> 10) -

You may not qualify if:

• Concomitant use of antidepressants (including serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants, buspirone, and thioridazine).
• Initiation of psychotherapy within 8 weeks.
• Inability or unwillingness to monitor ambulatory blood pressure and receive a blood pressure monitor via postal mail.
• Cirrhosis with clinically evident hepatic insufficiency (Child-Pugh Class B or C) by medical record review.1
• Severe renal impairment (on dialysis; chronic kidney disease stage 4-5; acute kidney injury with glomerular filtration rate \<30 mL/minute) by medical record review of labs performed within 18 months.
• Concurrent participation in another clinical trial of an investigational medicinal product.
• Pregnant or lactating either by self-report or medical record review
• Glaucoma
• Gastroparesis
• Use of medications that could lead to serious interactions with the study medication: potent CYP1A2 inhibitors, antidepressants (including serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, buspirone, thioridazine), linezolid, intravenous methylene blue, triptans, lithium, fentanyl, tramadol, meperidine, methadone, tryptophan, amphetamines, and St. John's Wort.
• Bipolar, psychotic, alcohol use disorder, non-alcohol substance-induced disorders, or imminent danger to self or others

Sponsors & Collaborators

• University of Pennsylvania: lead

Related Publications (3)

• 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.

  PMID: 37160297 RESULT

• 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.

  PMID: 40258375 RESULT

• 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.

  PMID: 26600836 RESULT

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Chung Tse, MD

CONTACT

2153498222; Chung.Tse@Pennmedicine.upenn.edu

Maureen DeMarshall, BSN, RN

CONTACT

2153498546; demarshm@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-02