Phase 4
N=15
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
Irritable Bowel Syndrome · Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00961298 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Clinical Global Impression Scale — 2.64 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Duloxetine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- West Penn Allegheny Health System
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression Scale |
2.64 | — |
| SECONDARY Hamilton Anxiety Rating Scale |
9.75 | — |
| SECONDARY Irritable Bowel Syndrome-Quality of Life Scale |
81.73 | — |
| SECONDARY Irritable Bowel Syndrome Severity Scoring System |
187.09 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00961298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.