Duloxetine in Inflammatory Bowel Diseases

Официальное название

A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Duloxetine
  antidepressant; central neuromodulator

Первичные конечные точки

• Change in IBD-related disability [Срок оценки: 6 weeks]

Вторичные конечные точки (3)

• Changes in psychological distress [Срок оценки: 6 weeks]
• Tolerability and safety [Срок оценки: 6 weeks]
• Changes in gastrointestinal-specific anxiety [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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) -

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Pennsylvania — Philadelphia

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07431606 · 859508

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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