Irritable Bowel Syndrome Clinical Trial
Official title:
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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