An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome Without Comorbid Major Depressive Disorder
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mclean Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).
Study Overview
Brief Summary
We hypothesize that duloxetine treatment will be associated with improvement in symptoms of IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder.
During this 12-week, open-label, outpatient study, male and female subjects between the ages of 18 and 65 years who have been diagnosed with irritable bowel syndrome (IBS) will be treated with open-label duloxetine.
Detailed Description
IBS is a chronic gastrointestinal disorder characterized by abdominal pain, altered bowel habits, and abdominal bloating for which no organic cause can be determined. Duloxetine has demonstrated efficacy in the treatment of depression as well as in several pain syndromes including diabetic peripheral neuropathy and fibromyalgia. We hypothesize that it will be a safe and efficacious treatment for the symptoms of IBS, in particular abdominal pain.
We plan to study 15 male and female subjects between the ages of 18 and 65 years who have had gastrointestinal symptoms at least 2 days/week for greater than six months and who have been diagnosed with IBS by a physician. During the 12-week study, subjects will receive open-label duloxetine titrated up to 60mg/day. Subjects will be asked to complete a total of ten study visits during the 12-week study period. All study visits will be conducted at McLean Hospital.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-65 years of age
- •Subjects must have been diagnosed with irritable bowel syndrome by a physician
- •Subjects must have had gastrointestinal symptoms for 2 or more days per week for > 6 months
Exclusion Criteria
- •Lifetime history of bipolar disorder, psychotic disorder, or obsessive-compulsive disorder
- •Current (within past 6 months) diagnosis of major depressive disorder or substance abuse disorder
- •Active suicidal/homicidal ideation
- •Pregnant women or women of child-bearing potential not using an approved methods of contraception
- •Individuals with an unstable medical condition that in the opinion of the investigator would interfere with the interpretation of symptoms
Arms & Interventions
1
12-week, open-label trial of duloxetine in subjects with IBS.
Intervention: duloxetine (Drug)
Outcomes
Primary Outcomes
Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).
Time Frame: baseline and week 12
Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.
Secondary Outcomes
- Brief Pain Inventory(At each visit)
- Short Form McGill Pain Questionnaire(At each visit)
- Clinical Global Impression Scale(At each visit)
- Hamilton Depression Rating Scale(At first visit only)
- Hamilton Anxiety Rating Scale(At baseline and week 12)
- Irritable Bowel Syndrome-Quality of Life Scale(At baseline and week 12)
- Sheehan Disability Scale(At baseline and week 12)
Investigators
Brian P. Brennan, MD
Associate Director of Translational Neuroscience Research
Mclean Hospital