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An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00961298
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : July 9, 2014
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):
Alicia Kaplan, West Penn Allegheny Health System

Tracking Information
First Submitted Date  ICMJE August 17, 2009
First Posted Date  ICMJE August 18, 2009
Results First Submitted Date  ICMJE March 14, 2014
Results First Posted Date  ICMJE July 9, 2014
Last Update Posted Date July 9, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2014)
Clinical Global Impression Scale [ Time Frame: endpoint [12 weeks] ]
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."
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2009)
Clinical Global Impression Scale [ Time Frame: at each visit post initial evaluation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2014)
  • Hamilton Anxiety Rating Scale [ Time Frame: endpoint [12 weeks] ]
    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 [ Time Frame: endpoint [12 weeks] ]
    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 [ Time Frame: endpoint [12 weeks] ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2009)
  • Hamilton Anxiety Rating Scale [ Time Frame: at each visit post initial evaluation ]
  • Irritable Bowel Syndrome-Quality of Life Scale [ Time Frame: at visits -2 (placebo run-in), 0,4,8,12,14 ]
  • Irritable Bowel Syndrome Severity Scoring System [ Time Frame: at each visit post initial evaluation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
Official Title  ICMJE An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Irritable Bowel Syndrome
  • Generalized Anxiety Disorder
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Duloxetine
Two weeks of placebo run in followed by 12 weeks of Duloxetine.
Intervention: Drug: Duloxetine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2014)
17
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2009)
30
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00961298
Other Study ID Numbers  ICMJE RC-4656
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alicia Kaplan, West Penn Allegheny Health System
Study Sponsor  ICMJE West Penn Allegheny Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alicia J Kaplan, MD West Penn Allegheny Health System
PRS Account West Penn Allegheny Health System
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP