A Phase II Open-label Study of Duloxetine to Reduce Inflammatory Bowel Disease-Related Disability and Psychological Distress
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in IBD-related disability
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) -
排除标准
- •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
- •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
研究组 & 干预措施
Duloxetine
Duloxetine 30-60 mg daily per oral
干预措施: Duloxetine (Drug)
结局指标
主要结局
Change in IBD-related disability
时间窗: 6 weeks
IBD Disability Index scores, range 0-100, higher score indicates more disability
次要结局
- Changes in psychological distress(6 weeks)
- Tolerability and safety(6 weeks)
- Changes in gastrointestinal-specific anxiety(6 weeks)
研究者
Chung Sang Tse
Assistant Professor of Medicine
University of Pennsylvania