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

NCT00961298 | Completed Phase 4 Results

• 1 other identifier: RC-4656
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome; Generalized Anxiety Disorder

Keywords

IBS; Irritable Bowel Syndrome; GAD; Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• 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."

  endpoint [12 weeks]

Secondary Outcomes (3)

• Hamilton Anxiety Rating Scale

  endpoint [12 weeks]

• Irritable Bowel Syndrome-Quality of Life Scale

  endpoint [12 weeks]

• Irritable Bowel Syndrome Severity Scoring System

  endpoint [12 weeks]

Study Arms (1)

Duloxetine

EXPERIMENTAL

Two weeks of placebo run in followed by 12 weeks of Duloxetine.

Drug: Duloxetine

Interventions

Duloxetine DRUG

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.

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Penn Allegheny Health System: lead

Related Publications (1)

• 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.

  PMID: 23980534 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Generalized Anxiety Disorder

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

A limitation of this pilot study was its small sample size and open label design. Another limitation may be that the patient sample is not representative of a true cross section of the GAD population as a whole.

Results Point of Contact

• Title: Alicia Kaplan MD
• Organization: Allegheny General Hospital

akaplan@wpahs.org

412-330-4069

Study Officials

• Alicia J Kaplan, MD

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 18, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 9, 2014
• Results First Posted: July 9, 2014

Record last verified: 2014-06