Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
West Penn Allegheny Health System
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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
