{"protocolSection":{"identificationModule":{"nctId":"NCT01015976","orgStudyIdInfo":{"id":"200803-272"},"organization":{"fullName":"Neuropsychiatric Research Institute, Fargo, North Dakota","class":"OTHER"},"briefTitle":"A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects","officialTitle":"A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects"},"statusModule":{"statusVerifiedDate":"2014-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-02"},"primaryCompletionDateStruct":{"date":"2010-04","type":"ACTUAL"},"completionDateStruct":{"date":"2010-04","type":"ACTUAL"},"studyFirstSubmitDate":"2009-10-01","studyFirstSubmitQcDate":"2009-11-17","studyFirstPostDateStruct":{"date":"2009-11-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-10-28","resultsFirstSubmitQcDate":"2014-02-13","resultsFirstPostDateStruct":{"date":"2014-03-31","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-02-13","lastUpdatePostDateStruct":{"date":"2014-03-31","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"James Roerig","investigatorTitle":"James L. Roerig, Pharm.D., BCPP, University of North Dakota Department of Clinical Neuroscience, Grand Forks, ND and the Neuropsychiatric Research Institute, Fargo, ND.","investigatorAffiliation":"Neuropsychiatric Research Institute, Fargo, North Dakota"},"leadSponsor":{"name":"Neuropsychiatric Research Institute, Fargo, North Dakota","class":"OTHER"},"collaborators":[{"name":"University of North Dakota","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine the difference, if any, in the area under the sertraline plasma level time curve (AUC) between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.","detailedDescription":"Secondary objectives include the determination of changes in mean CPmax, Time to CPmax and Volume of Distribution between the two groups. Also, assessment of subject tolerance of sertraline utilizing the UKU side effect rating scale."},"conditionsModule":{"conditions":["Obesity"],"keywords":["Gastric Bypass","Sertraline","Pharmacokinetics"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":10,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Post bariatric surgery","type":"EXPERIMENTAL","description":"Roux en Y bariatric surgery","interventionNames":["Procedure: bariatric surgery"]},{"label":"Control","type":"OTHER","description":"No surgery","interventionNames":["Other: control"]}],"interventions":[{"type":"PROCEDURE","name":"bariatric surgery","description":"Roux en Y bariatric surgery","armGroupLabels":["Post bariatric surgery"]},{"type":"OTHER","name":"control","description":"No surgery","armGroupLabels":["Control"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"AUC Post Surgery (n =5) Compared to AUC Control (n=5)","description":"AUC of surgery group compared to the AUC of control group","timeFrame":"0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female subjects between the ages of 18 and 60 years.\n* Subjects must be of good general health by history and physical exam.\n* Five subjects 9 to 15 months past bariatric surgery (Roux-en-Y procedure), no BMI requirement.\n* Five subjects matched for body mass index, age and sex to the post bariatric surgery group.\n* No contraindications to receiving a single dose of 100 mg of sertraline.\n* Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraception) and have a negative pregnancy test at baseline.\n\nExclusion Criteria:\n\n* Allergy to sertraline or any of its constituents.\n* Candidates currently receiving sertraline or any other antidepressant.\n* Candidates currently receiving a medication that interacts with sertraline (Zoloft)\n* Candidates who are poor metabolizers for the CYP2D6 and/or 2C19 enzymes.\n* Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.\n* Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder.\n* Candidates who have participated in an investigational drug study in past 30 days.\n* Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.\n* Candidates who are pregnant or nursing at time of study.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"James Roerig, PharmD, BCPP","affiliation":"Neuropsychiatric Research Institute and University of North Dakota","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Neuropsychiatric Research Institute","city":"Fargo","state":"North Dakota","zip":"58103","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Experimental","description":"Post surgery group Sertraline : Single dose of 100mg sertraline"},{"id":"FG001","title":"Control Group","description":"active drug\n\nNo surgery matched subjects"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Active Drug","description":"Single arm study, all receive active drug\n\nSertraline : Single dose of 100mg sertraline"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"10"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"10"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.6","spread":"10.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"10"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"AUC Post Surgery (n =5) Compared to AUC Control (n=5)","description":"AUC of surgery group compared to the AUC of control group","populationDescription":"Per protocol","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng-hr/mL","timeFrame":"0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours","groups":[{"id":"OG000","title":"Control","description":"Single arm study, all receive active drug\n\nSertraline : Single dose of 100mg sertraline"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"}]}],"classes":[{"title":"Post surgery","categories":[{"measurements":[{"groupId":"OG000","value":"124.4","spread":"55.5"}]}]},{"title":"Control","categories":[{"measurements":[{"groupId":"OG000","value":"314.8","spread":"129.6"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Active Drug","description":"Two arm study, all receive active drug\n\nSertraline : Single dose of 100mg sertraline","seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":0,"otherNumAtRisk":10}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"small sample size absence of men in either group. short data collection period, characterization of the linear elimination phase of the AUC was not possible."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"James L. Roerig PharmD, BCPP","organization":"University of North Dakota - Neuropsychiatric Research Institute","email":"jroerig@nrifargo.com","phone":"701 365 4919"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"}],"ancestors":[{"id":"D050177","term":"Overweight"},{"id":"D044343","term":"Overnutrition"},{"id":"D009748","term":"Nutrition Disorders"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D050110","term":"Bariatric Surgery"}],"ancestors":[{"id":"D049088","term":"Bariatrics"},{"id":"D000073319","term":"Obesity Management"},{"id":"D013812","term":"Therapeutics"},{"id":"D013514","term":"Surgical Procedures, Operative"}]}},"hasResults":true}