An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder - NCT00961298-15212 (Clinical Trial 306278)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy306278.aspx
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| City: |
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Pittsburgh |
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State:
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PA |
| Zip Code: |
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15212 |
| Conditions: |
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Irritable Bowel Syndrome - Generalized Anxiety Disorder |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Allegheny General Hospital
Pittsburgh, PA 15212
United States
Primary Contact:
Alicia J Kaplan, MD
Email: akaplan@wpahs.org
Phone: 412-330-4335
Secondary Contact:
Alicia J Kaplan, MD
Email: akaplan@wpahs.org
Phone: 412-330-4335 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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