Inflammatory Bowel DiseasesPhase 2Duloxetine inNCT07431606
Duloxetine in Inflammatory Bowel Diseases
A Phase 2 study testing Duloxetine in people with Inflammatory Bowel Diseases, run by University of Pennsylvania at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 24 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) -
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Chung Tse, MD, 2153498222, Chung.Tse@Pennmedicine.upenn.edu
Maureen DeMarshall, RN, 2153498546, demarshm@pennmedicine.upenn.edu
About this study
Official title: A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress
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
Read the detailed description
Subjects will be screened and enrolled once PI confirms eligibility. After patient signs consent:
Duloxetine 30 mg orally daily will be administered for 1 week (age <65 years) or 2 weeks (age ≥65 years), then increased to duloxetine 60 mg orally daily, if tolerated.
Patients may continue duloxetine 30 mg if they do not tolerate duloxetine 60 mg.
Patients will receive 30-60 mg of duloxetine for 6 weeks, followed by a tapering period of 2 weeks at the end of treatment, mailed to their home address. Patients who wish to continue taking duloxetine after the trial may contact their primary care provider to obtain a prescription for duloxetine.
Patient reported outcomes will be completed at set intervals.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Duloxetine
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called cymbalta
antidepressant; central neuromodulator
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Duloxetine 30-60 mg daily per oral Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IBD-related disability
IBD Disability Index scores, range 0-100, higher score indicates more disability
Measured: 6 weeks
Secondary outcomes (3)
Changes in psychological distress
Depression Anxiety and Stress Scale (DASS-21), range 0-21, higher scores indicate higher distress Distress Thermometer, range 0-10, higher scores indicate higher distress
Measured: 6 weeks
Tolerability and safety
Determine the tolerability and safety of duloxetine (30-60 mg daily)
Measured: 6 weeks
Changes in gastrointestinal-specific anxiety
Visceral Sensitivity Index (VSI), range 0-75, higher scores indicate more gastrointestinal-specific anxiety
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 May 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Sang Tse, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431606
- Sponsor's protocol ID
- 859508
- Acronym
- Duloxetine in
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37160297Khasawneh 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.
PubMed 40258375Daghaghzadeh 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.
PubMed 26600836
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress
- ClinicalTrials.gov ID
- NCT07431606
- Acronym / sponsor ID
- Duloxetine in / 859508
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Subjects will be screened and enrolled once PI confirms eligibility. After patient signs consent:
Duloxetine 30 mg orally daily will be administered for 1 week (age <65 years) or 2 weeks (age ≥65 years), then increased to duloxetine 60 mg orally daily, if tolerated.
Patients may continue duloxetine 30 mg if they do not tolerate duloxetine 60 mg.
Patients will receive 30-60 mg of duloxetine for 6 weeks, followed by a tapering period of 2 weeks at the end of treatment, mailed to their home address. Patients who wish to continue taking duloxetine after the trial may contact their primary care provider to obtain a prescription for duloxetine.
Patient reported outcomes will be completed at set intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: DuloxetineDuloxetine 30-60 mg daily per oral |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: cymbaltaantidepressant; central neuromodulator | Drug | Duloxetine |
Primary outcome
Change in IBD-related disability
Time frame: 6 weeks
IBD Disability Index scores, range 0-100, higher score indicates more disability
3 secondary outcomes
Changes in psychological distress
Time frame: 6 weeks
Tolerability and safety
Time frame: 6 weeks
Changes in gastrointestinal-specific anxiety
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Results publication: PubMed 37160297Birkinshaw 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 publication: PubMed 40258375Khasawneh 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 publication: PubMed 26600836Daghaghzadeh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine in people with Inflammatory Bowel Diseases, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chung Tse, MD (2153498222, Chung.Tse@Pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IBD-related disability (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07431606, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.