An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Clinical Global Impression Scale
研究概览
简要总结
The investigators propose to evaluate the effectiveness of duloxetine in treating subjects with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The investigators hypothesize that duloxetine as a single therapeutic agent will effectively target pain and other core symptoms of IBS as well as GAD in this patient population with both conditions.
详细描述
Generalized Anxiety Disorder (GAD) is commonly associated with Irritable Bowel Syndrome(IBS). The etiology of IBS remains unknown and it is often refractory to treatment. Duloxetine has demonstrated efficacy in the treatment of GAD as well as other pain disorders including fibromyalgia and diabetic neuropathy.
We plan to study 30 subjects with diagnoses of IBS and GAD between the ages of 18 and 65 years. There will be a single-blind placebo-run-in for the first 2 weeks, followed by open-label duloxetine for 12 weeks flexibly titrated to 120 mg/day. Subjects will be informed that they will receive placebo for 2 weeks during the trial. All study visits will be at Allegheny General Hospital Department of Psychiatry. The study consists of a total of nine office visits.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •Active IBS diagnosis by a gastroenterologist
- •Generalized Anxiety Disorder diagnosed by DSM-IV TR criteria and the Mini International Neuropsychiatric Interview for the DSM-IV (Mini)
- •No changes in any non study medication once starting the study
排除标准
- •Current diagnoses of Major Depressive Disorder, Panic Disorder, Social Phobia, Post Traumatic Stress Disorder, Obsessive Compulsive Disorders, Eating Disorders, Somatoform Disorders, Drug or alcohol abuse or dependence, or severe personality disorder
- •Lifetime history of any Bipolar Disorder or Psychotic Disorder
- •Concurrent GI disorders falling outside of Rome III Functional GI disorders
- •Pregnant women or sexually active female subjects not using medically acceptable method of contraception
- •Current suicidal ideation
- •Unstable medical condition
研究组 & 干预措施
Duloxetine
Two weeks of placebo run in followed by 12 weeks of Duloxetine.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Clinical Global Impression Scale
时间窗: endpoint [12 weeks]
The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale. The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 "very much improved", 4 "no change", and 7 "very much worse."
次要结局
- Irritable Bowel Syndrome-Quality of Life Scale(endpoint [12 weeks])
- Hamilton Anxiety Rating Scale(endpoint [12 weeks])
- Irritable Bowel Syndrome Severity Scoring System(endpoint [12 weeks])
研究者
Alicia Kaplan
MD
West Penn Allegheny Health System