Recruiting
Phase 2

Duloxetine

Sponsor:

University of Pennsylvania

Code:

NCT07431606

Conditions

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 24+

Healthy Volunteers: Not accepted

Interventions

Duloxetine

Study Details

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

Study ID

NCT07431606

Start date

May 1, 2026

Status verified date

Feb, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 24+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. elevated psychological distress (Distress Thermometer score > 4),10-12
2. moderate-to-severe IBD-related disability (IBD-DI score ≥ 356, 7), or
3. elevated GI-specific anxiety (Visceral Sensitivity Index > 10) -

Exclusion Criteria:

  • 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

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Duloxetine

Duloxetine 30-60 mg daily per oral

Interventions

Duloxetine

antidepressant; central neuromodulator

Primary outcome measure

  • Change in IBD-related disability [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Chung Tse, MD

2153498222Chung.Tse@Pennmedicine.upenn.edu

Maureen DeMarshall, BSN, RN

2153498546demarshm@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Chung Tse, MD

2153498222Chung.Tse@Pennmedicine.upenn.edu

Maureen DeMarshall, RN

2153498546demarshm@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Jul 16, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-07-16.