{"protocolSection":{"identificationModule":{"nctId":"NCT00961298","orgStudyIdInfo":{"id":"RC-4656"},"organization":{"fullName":"West Penn Allegheny Health System","class":"OTHER"},"briefTitle":"An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder","officialTitle":"An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder"},"statusModule":{"statusVerifiedDate":"2014-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-09"},"primaryCompletionDateStruct":{"date":"2011-12","type":"ACTUAL"},"completionDateStruct":{"date":"2011-12","type":"ACTUAL"},"studyFirstSubmitDate":"2009-08-17","studyFirstSubmitQcDate":"2009-08-17","studyFirstPostDateStruct":{"date":"2009-08-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-03-14","resultsFirstSubmitQcDate":"2014-06-08","resultsFirstPostDateStruct":{"date":"2014-07-09","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-06-08","lastUpdatePostDateStruct":{"date":"2014-07-09","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Alicia Kaplan","investigatorTitle":"MD","investigatorAffiliation":"West Penn Allegheny Health System"},"leadSponsor":{"name":"West Penn Allegheny Health System","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"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.","detailedDescription":"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.\n\nWe 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."},"conditionsModule":{"conditions":["Irritable Bowel Syndrome","Generalized Anxiety Disorder"],"keywords":["IBS","Irritable Bowel Syndrome","GAD","Generalized Anxiety Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["PARTICIPANT"]}},"enrollmentInfo":{"count":17,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"EXPERIMENTAL","description":"Two weeks of placebo run in followed by 12 weeks of Duloxetine.","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","description":"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.","armGroupLabels":["Duloxetine"],"otherNames":["Cymbalta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Clinical Global Impression Scale","description":"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.\n\nThe 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.\"","timeFrame":"endpoint [12 weeks]"}],"secondaryOutcomes":[{"measure":"Hamilton Anxiety Rating Scale","description":"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.","timeFrame":"endpoint [12 weeks]"},{"measure":"Irritable Bowel Syndrome-Quality of Life Scale","description":"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.","timeFrame":"endpoint [12 weeks]"},{"measure":"Irritable Bowel Syndrome Severity Scoring System","description":"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.","timeFrame":"endpoint [12 weeks]"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 18-65 years of age\n* Active IBS diagnosis by a gastroenterologist\n* Generalized Anxiety Disorder diagnosed by DSM-IV TR criteria and the Mini International Neuropsychiatric Interview for the DSM-IV (Mini)\n* No changes in any non study medication once starting the study\n\nExclusion Criteria:\n\n* 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\n* Lifetime history of any Bipolar Disorder or Psychotic Disorder\n* Concurrent GI disorders falling outside of Rome III Functional GI disorders\n* Pregnant women or sexually active female subjects not using medically acceptable method of contraception\n* Current suicidal ideation\n* Unstable medical condition","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Alicia J Kaplan, MD","affiliation":"West Penn Allegheny Health System","role":"PRINCIPAL_INVESTIGATOR"}]},"referencesModule":{"references":[{"pmid":"23980534","type":"DERIVED","citation":"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."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Two participants were considered screen failures and were not entered into the placebo run in phase.","recruitmentDetails":"Subjects were referred by a gastroenterologist who had Irritable Bowel Syndrome and anxiety.","groups":[{"id":"FG000","title":"Treatment Arm","description":"Every study eligible subject entered a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine."}],"periods":[{"title":"Two Week Placebo Run in","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"15"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]},{"title":"12 Weeks Duloxetine Treatment Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"14"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Treatment Arm","description":"every subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"15"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42.54","spread":"12.70"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"13"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"15"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Clinical Global Impression Scale","description":"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.\n\nThe 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.\"","populationDescription":"per protocol","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"endpoint [12 weeks]","groups":[{"id":"OG000","title":"Treatment Arm","description":"every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.64","spread":"0.5"}]}]}]},{"type":"SECONDARY","title":"Hamilton Anxiety Rating Scale","description":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"endpoint [12 weeks]","groups":[{"id":"OG000","title":"Treatment Arm","description":"every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.75","spread":"4.5"}]}]}]},{"type":"SECONDARY","title":"Irritable Bowel Syndrome-Quality of Life Scale","description":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"endpoint [12 weeks]","groups":[{"id":"OG000","title":"Treatment Arm","description":"every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"81.73","spread":"19.25"}]}]}]},{"type":"SECONDARY","title":"Irritable Bowel Syndrome Severity Scoring System","description":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"endpoint [12 weeks]","groups":[{"id":"OG000","title":"Treatment Arm","description":"every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"187.09","spread":"54.05"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"within 14 weeks.","description":"patient interview at study visit.","eventGroups":[{"id":"EG000","title":"Treatment Arm","description":"every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.","seriousNumAffected":0,"seriousNumAtRisk":15,"otherNumAffected":9,"otherNumAtRisk":15}],"otherEvents":[{"term":"constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":15}]},{"term":"nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":15}]},{"term":"fatigue","organSystem":"General disorders","sourceVocabulary":"other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":15}]},{"term":"dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":15}]},{"term":"anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":15}]},{"term":"dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":15}]},{"term":"weight gain","organSystem":"Endocrine disorders","sourceVocabulary":"other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":15}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"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."},"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Alicia Kaplan MD","organization":"Allegheny General Hospital","email":"akaplan@wpahs.org","phone":"412-330-4069"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","removedCountries":["United States"]},"conditionBrowseModule":{"meshes":[{"id":"D043183","term":"Irritable Bowel Syndrome"},{"id":"D000098647","term":"Generalized Anxiety Disorder"}],"ancestors":[{"id":"D003109","term":"Colonic Diseases, Functional"},{"id":"D003108","term":"Colonic Diseases"},{"id":"D007410","term":"Intestinal Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D001008","term":"Anxiety Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D000068736","term":"Duloxetine Hydrochloride"}],"ancestors":[{"id":"D013876","term":"Thiophenes"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}