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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alicia Kaplan, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00961298
First received: August 17, 2009
Last updated: June 8, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome
Generalized Anxiety Disorder
Drug: Duloxetine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:
  • Clinical Global Impression Scale [ Time Frame: endpoint [12 weeks] ] [ Designated as safety issue: No ]

    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 [ Time Frame: endpoint [12 weeks] ] [ Designated as safety issue: No ]
    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] ] [ Designated as safety issue: No ]
    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] ] [ Designated as safety issue: No ]
    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.


Enrollment: 17
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961298

Sponsors and Collaborators
West Penn Allegheny Health System
Investigators
Principal Investigator: Alicia J Kaplan, MD West Penn Allegheny Health System
  More Information

No publications provided by West Penn Allegheny Health System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alicia Kaplan, MD, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT00961298     History of Changes
Other Study ID Numbers: RC-4656
Study First Received: August 17, 2009
Results First Received: March 14, 2014
Last Updated: June 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:
IBS
Irritable Bowel Syndrome
GAD
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Syndrome
Irritable Bowel Syndrome
Mental Disorders
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014