An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
Primary Purpose
Irritable Bowel Syndrome, Generalized Anxiety Disorder
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, Irritable Bowel Syndrome, GAD, Generalized Anxiety Disorder
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Duloxetine
Arm Description
Two weeks of placebo run in followed by 12 weeks of Duloxetine.
Outcomes
Primary Outcome Measures
Clinical Global Impression Scale
The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale.
The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 "very much improved", 4 "no change", and 7 "very much worse."
Secondary Outcome Measures
Hamilton Anxiety Rating Scale
The HAM-A is a 14 question scale with five responses. Responses range from 0 "not present" to 4 "very severe." The total score ranges from 0 to 56. Higher values represent a worse outcome.
Irritable Bowel Syndrome-Quality of Life Scale
The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 "not at all" to 5 "extremely" or "a great deal" Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170.
Irritable Bowel Syndrome Severity Scoring System
This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome.
Full Information
NCT ID
NCT00961298
First Posted
August 17, 2009
Last Updated
June 8, 2014
Sponsor
West Penn Allegheny Health System
1. Study Identification
Unique Protocol Identification Number
NCT00961298
Brief Title
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
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Penn Allegheny Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Generalized Anxiety Disorder
Keywords
IBS, Irritable Bowel Syndrome, GAD, Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine
Arm Type
Experimental
Arm Description
Two weeks of placebo run in followed by 12 weeks of Duloxetine.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Global Impression Scale
Description
The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale.
The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 "very much improved", 4 "no change", and 7 "very much worse."
Time Frame
endpoint [12 weeks]
Secondary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale
Description
The HAM-A is a 14 question scale with five responses. Responses range from 0 "not present" to 4 "very severe." The total score ranges from 0 to 56. Higher values represent a worse outcome.
Time Frame
endpoint [12 weeks]
Title
Irritable Bowel Syndrome-Quality of Life Scale
Description
The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 "not at all" to 5 "extremely" or "a great deal" Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170.
Time Frame
endpoint [12 weeks]
Title
Irritable Bowel Syndrome Severity Scoring System
Description
This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome.
Time Frame
endpoint [12 weeks]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia J Kaplan, MD
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23980534
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.
Results Reference
derived
Learn more about this trial
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
We'll reach out to this number within 24 hrs