An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West Penn Allegheny Health System
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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