Clinical trial NCT00961298: An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
Official title: An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Generalized Anxiety Disorder
Keywords: IBS
Irritable Bowel Syndrome
GAD
Generalized Anxiety Disorder
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
First posted: 2009-08-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

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

Primary outcomes:
measure: Clinical Global Impression Scale
timeFrame: endpoint [12 weeks]
Secondary outcomes:
measure: Hamilton Anxiety Rating Scale
timeFrame: endpoint [12 weeks]
measure: Irritable Bowel Syndrome-Quality of Life Scale
timeFrame: endpoint [12 weeks]
measure: Irritable Bowel Syndrome Severity Scoring System
timeFrame: endpoint [12 weeks]
Other outcomes:
Locations:
Study officials:
affiliation: West Penn Allegheny Health System
name: Alicia J Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaplan A, Franzen MD, Nickell PV, Ransom D, Lebovitz PJ. An open-label trial of duloxetine in patients with irritable bowel syndrome and comorbid generalized anxiety disorder. Int J Psychiatry Clin Pract. 2014 Jan;18(1):11-5. doi: 10.3109/13651501.2013.838632. Epub 2013 Sep 20.