An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
This study has been completed.
Sponsor:
West Penn Allegheny Health System
Information provided by (Responsible Party):
Alicia Kaplan, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00961298
First received: August 17, 2009
Last updated: October 28, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome Generalized Anxiety Disorder |
Drug: Duloxetine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder |
Resource links provided by NLM:
Further study details as provided by West Penn Allegheny Health System:
Primary Outcome Measures:
- Clinical Global Impression Scale [ Time Frame: weeks -2, 0, 2,4,6,8,12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hamilton Anxiety Rating Scale [ Time Frame: weeks -2, 0, 2,4,6,8,12 ] [ Designated as safety issue: No ]
- Irritable Bowel Syndrome-Quality of Life Scale [ Time Frame: weeks -2, 0,4,8,12 ] [ Designated as safety issue: No ]
- Irritable Bowel Syndrome Severity Scoring System [ Time Frame: weeks -2,0,2,4,6,8,12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2009 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Duloxetine
All subjects will receive single-blind placebo for the first two weeks, and then duloxetine for the next 12 weeks, followed by an up to 2 week taper off of the duloxetine. After 2 weeks of placebo daily, subjects will receive 30 mg per day of duloxetine for two weeks, then titrated up to 60 mg per day of duloxetine at week 2. A dosage decrease to 30 mg daily is permittable after week 2. This will be a flexible dose study with doses of duloxetine progressively increasing at weeks 4 (90 mg daily) and 6 (120 mg daily) in conjunction with CGI-I scores, to reach 120 mg daily or the maximum tolerated dose, if less than 120 mg daily at Week 12. There will be a post-taper follow up appointment at Week 14. Of Note: Amendment IRB Approved 6/14/11 Study Ending at Week 12 with removal of Week 14 visit as part of study.
Other Name: Cymbalta
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Alicia Kaplan, MD, West Penn Allegheny Health System |
| ClinicalTrials.gov Identifier: | NCT00961298 History of Changes |
| Other Study ID Numbers: | RC-4656 |
| Study First Received: | August 17, 2009 |
| Last Updated: | October 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by West Penn Allegheny Health System:
|
IBS Irritable Bowel Syndrome GAD Generalized Anxiety Disorder |
Additional relevant MeSH terms:
|
Anxiety Disorders Irritable Bowel Syndrome Mental Disorders Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013