Status:
COMPLETED
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
Lead Sponsor:
West Penn Allegheny Health System
Conditions:
Irritable Bowel Syndrome
Generalized Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 hypothesiz...
Detailed Description
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00961298
Start Date
September 1 2009
End Date
December 1 2011
Last Update
July 9 2014
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