search
Back to results

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
West Penn Allegheny Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 17, 2009
    Last Updated
    June 8, 2014
    Sponsor
    West Penn Allegheny Health System
    search

    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