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.
Irritable Bowel Syndrome
Generalized Anxiety Disorder
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder|
- Clinical Global Impression Scale [ Time Frame: weeks -2, 0, 2,4,6,8,12 ] [ Designated as safety issue: No ]
- Hamilton Anxiety Rating Scale [ Time Frame: weeks -2, 0, 2,4,6,8,12 ] [ Designated as safety issue: No ]
- Irritable Bowel Syndrome-Quality of Life Scale [ Time Frame: weeks -2, 0,4,8,12 ] [ Designated as safety issue: No ]
- Irritable Bowel Syndrome Severity Scoring System [ Time Frame: weeks -2,0,2,4,6,8,12 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.