Clinical trial NCT00401258: An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome
Official title: An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome Without Comorbid Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: IBS
irritable bowel syndrome
irritable bowel
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2006-11-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).
timeFrame: baseline and week 12
Secondary outcomes:
measure: Brief Pain Inventory
timeFrame: At each visit
measure: Short Form McGill Pain Questionnaire
timeFrame: At each visit
measure: Clinical Global Impression Scale
timeFrame: At each visit
measure: Hamilton Depression Rating Scale
timeFrame: At first visit only
measure: Hamilton Anxiety Rating Scale
timeFrame: At baseline and week 12
measure: Irritable Bowel Syndrome-Quality of Life Scale
timeFrame: At baseline and week 12
measure: Sheehan Disability Scale
timeFrame: At baseline and week 12
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Brian P Brennan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brennan BP, Fogarty KV, Roberts JL, Reynolds KA, Pope HG Jr, Hudson JI. Duloxetine in the treatment of irritable bowel syndrome: an open-label pilot study. Hum Psychopharmacol. 2009 Jul;24(5):423-8. doi: 10.1002/hup.1038.