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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00961298
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : July 9, 2014
Last Update Posted : July 9, 2014
Information provided by (Responsible Party):
Alicia Kaplan, West Penn Allegheny Health System

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Generalized Anxiety Disorder Drug: Duloxetine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
Study Start Date : September 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Duloxetine
Two weeks of placebo run in followed by 12 weeks of Duloxetine.
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

Primary Outcome Measures :
  1. 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."

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00961298

Sponsors and Collaborators
West Penn Allegheny Health System
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Principal Investigator: Alicia J Kaplan, MD West Penn Allegheny Health System
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alicia Kaplan, MD, West Penn Allegheny Health System Identifier: NCT00961298    
Other Study ID Numbers: RC-4656
First Posted: August 18, 2009    Key Record Dates
Results First Posted: July 9, 2014
Last Update Posted: July 9, 2014
Last Verified: June 2014
Keywords provided by Alicia Kaplan, West Penn Allegheny Health System:
Irritable Bowel Syndrome
Generalized Anxiety Disorder
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Anxiety Disorders
Pathologic Processes
Mental Disorders
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents