{"protocolSection":{"identificationModule":{"nctId":"NCT02417142","orgStudyIdInfo":{"id":"13T-005"},"organization":{"fullName":"University of Massachusetts, Worcester","class":"OTHER"},"briefTitle":"Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia","officialTitle":"Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia"},"statusModule":{"statusVerifiedDate":"2022-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-07","type":"ACTUAL"},"completionDateStruct":{"date":"2020-07","type":"ACTUAL"},"studyFirstSubmitDate":"2015-04-10","studyFirstSubmitQcDate":"2015-04-10","studyFirstPostDateStruct":{"date":"2015-04-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2021-04-01","resultsFirstSubmitQcDate":"2021-05-20","resultsFirstPostDateStruct":{"date":"2021-06-15","type":"ACTUAL"},"dispFirstSubmitDate":"2020-09-29","dispFirstSubmitQcDate":"2020-09-29","dispFirstPostDateStruct":{"date":"2020-10-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-01-04","lastUpdatePostDateStruct":{"date":"2022-01-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Xiaoduo Fan","investigatorTitle":"Xiaoduo Fan, MD, MPH, MS","investigatorAffiliation":"University of Massachusetts, Worcester"},"leadSponsor":{"name":"University of Massachusetts, Worcester","class":"OTHER"},"collaborators":[{"name":"Stanley Medical Research Institute","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This is a 24-week, randomized, double-blind, placebo-controlled trial of exenatide weekly injection (2mg per dose) as an adjunctive therapy in 70 schizophrenia subjects to examine exenatide's effects on negative symptoms and cognition.","detailedDescription":"The specific aims include:\n\nPrimary aim:\n\n1\\. Examine the efficacy of exenatide weekly injection in improving negative symptoms as measured by the Scale for the Assessment of Negative Symptoms (SANS) total score.\n\nSecondary aims:\n\n1\\. Examine the efficacy of exenatide in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) composite score.\n\nTertiary/Exploratory aims:\n\n1. Examine exenatide's effect on schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) total score.\n2. Examine the efficacy of exenatide in improving social function as measured by the Instrumental Activities of Daily Living Scale (IADL) and the Heinrich Carpenter Quality of Life Scale (QLS).\n3. Examine exenatide's effect on neuro-protection as measured by the change in hippocampal volume.\n4. Examine exenatide's effects on inflammatory markers including serum levels of high sensitivity C-reactive Protein (CRP), Interleukin 6 (IL-6), and tumor necrosis factor (TNF-α).\n5. Examine the potential moderator role of baseline serum levels of C-reactive Protein (CRP), Interleukin 6 (IL-6), tumor necrosis factor (TNF-α), and baseline hippocampal volume for exenatide's effects on negative and cognitive symptoms.\n6. Examine the potential mediator role of changes from baseline in serum levels of C-reactive Protein (CRP), Interleukin 6 (IL-6), tumor necrosis factor (TNF-α), and hippocampal volume for exenatide's effects on negative and cognitive symptoms.\n7. Examine the efficacy of exenatide in reducing body weight and improving glucose metabolism as measured by fasting plasma glucose and HbA1c.\n8. Examine the safety and tolerability of exenatide as measured by changes in the side effects questionnaire (SEQ, SEQabbrev), EKG and vital signs"},"conditionsModule":{"conditions":["Schizophrenia","Schizoaffective Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":70,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Experimental","type":"EXPERIMENTAL","description":"Exenatide 2mg subcutaneous injection, once weekly","interventionNames":["Drug: Exenatide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Exenatide","description":"Exenatide SQ 2mg/week for 24 weeks.","armGroupLabels":["Experimental"],"otherNames":["Bydureon"]},{"type":"DRUG","name":"Placebo","description":"Placebo SQ 1x/week for 24 weeks.","armGroupLabels":["Placebo"],"otherNames":["Control"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score","description":"SANS measures negative symptoms on a 25-item, six point scale each (0-5; none-severe). Items are listed under five domains including affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. The total possible score ranges from 0 to 125.","timeFrame":"Baseline, Week 6, Week 12, Week 18 and Week 24"}],"secondaryOutcomes":[{"measure":"Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score","description":"The MATRICS Consensus Cognitive Battery (MCCB) measures cognition relevant to schizophrenia and related disorders. The MCCB consists of ten individually administered tests that measure cognitive performance in seven domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores from the ten tests are entered in the MCCB Computer Scoring Program software, which provides an age and gender-corrected T-score and percentile on the seven cognitive domains. A T-score of 50 +/- 10 represents a normative mean performance in each test. Accordingly, the criterion for assignment to cognitively normal-range group require an overall composite T-score from 40 to 60. These data points from baseline visit to week 24 will measure changes in cognition in addition overall cognitive ability compared to healthy individuals.","timeFrame":"Baseline, Week 6, Week 12, Week 18, and Week 24."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* age 18-65 years\n* diagnosis of schizophrenia or schizoaffective disorder\n* stable dose of the current antipsychotic drug for at least one month\n* well established compliance with outpatient treatment per treating clinician's judgment\n* able to complete the cognitive assessment battery (must be English speaking)\n* Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study\n\nExclusion Criteria:\n\n* inability to provide informed consent\n* current substance abuse\n* psychiatrically unstable per treating clinician's judgment\n* significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases\n* currently on anti-inflammatory or immunosuppressant medication including oral steroids\n* currently on sulfonylurea drugs (e.g. glyburide)\n* history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition\n* pregnant or breastfeeding\n* prisoners","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Xiaoduo Fan, MD, MPH, MS","affiliation":"University of Massachusetts, Worcester","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"UMass Medical School","city":"Worcester","state":"Massachusetts","zip":"01605","country":"United States","geoPoint":{"lat":42.26259,"lon":-71.80229}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) criteria for schizophrenia or schizoaffective disorder were enrolled in the study (see inclusion/exclusion criteria). Eligible subjects were randomly assigned to either the experimental or placebo group.","recruitmentDetails":"Single-site study conducted at University of Massachusetts (UMass) Medical School. Subjects were recruited from UMass Memorial Healthcare facilities and ambulatory clinics in Worcester, MA.","groups":[{"id":"FG000","title":"Experimental","description":"(existing treatment) + (Drug)\n\nIntervention:\n\nDrug: Exenatide\n\nExenatide: Exenatide 2mg/week subcutaneous injection for 24 weeks."},{"id":"FG001","title":"Placebo","description":"(existing treatment) + (Placebo)\n\nIntervention:\n\nDrug: Placebo\n\nPlacebo: Placebo IM for 24 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"35"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"22"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"13"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Experimental","description":"(existing treatment) + (Drug)\n\nIntervention:\n\nDrug: Exenatide\n\nExenatide: Exenatide IM 2mg/week for 24 weeks."},{"id":"BG001","title":"Placebo","description":"(existing treatment) + (Placebo)\n\nIntervention:\n\nDrug: Placebo\n\nPlacebo: Placebo IM for 24 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"70"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41.6","spread":"12.3"},{"groupId":"BG001","value":"43.9","spread":"11.9"},{"groupId":"BG002","value":"42.7","spread":"12.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"15"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"55"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"52"}]}]},{"title":"Black/African 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States","categories":[{"measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"70"}]}]}]},{"title":"Education","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12.9","spread":"2.4"},{"groupId":"BG001","value":"12.7","spread":"2.1"},{"groupId":"BG002","value":"12.8","spread":"2.3"}]}]}]},{"title":"Age of illness onset","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"23.7","spread":"8.3"},{"groupId":"BG001","value":"24.6","spread":"9.3"},{"groupId":"BG002","value":"24.2","spread":"8.8"}]}]}]},{"title":"Duration of illness","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"18.1","spread":"12.2"},{"groupId":"BG001","value":"18.9","spread":"10.1"},{"groupId":"BG002","value":"18.5","spread":"11.2"}]}]}]},{"title":"Schizophrenia","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"37"}]}]}]},{"title":"Schizoaffective disorder","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"33"}]}]}]},{"title":"Typical antipsychotic medication","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"22"}]},{"title":"No","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"48"}]}]}]},{"title":"Atypical antipsychotic medication","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"57"}]},{"title":"No","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"13"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score","description":"SANS measures negative symptoms on a 25-item, six point scale each (0-5; none-severe). Items are listed under five domains including affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. The total possible score ranges from 0 to 125.","populationDescription":"12 subjects in experimental arm withdrew or were lost to follow-up by week 24. 4 subjects in the experimental arm were removed from study by investigator by week 24.\n\n11 subjects in placebo arm withdrew or were lost to follow-up by week 24. 2 subjects in the placebo arm were removed from study by investigator by week 24.\n\nReasons for removal include inpatient hospitalization, increase in depressive symptoms, elevated HbA1c, starting insulin therapy and repeatedly missing visits.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Week 6, Week 12, Week 18 and Week 24","groups":[{"id":"OG000","title":"Experimental","description":"(existing treatment) + (Drug)\n\nIntervention:\n\nDrug: Exenatide\n\nExenatide: Exenatide IM 2mg/week for 24 weeks."},{"id":"OG001","title":"Placebo","description":"(existing treatment) + (Placebo)\n\nIntervention:\n\nDrug: Placebo\n\nPlacebo: Placebo IM for 24 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"35"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"35"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"33.1","spread":"12.9"},{"groupId":"OG001","value":"34.1","spread":"15.0"}]}]},{"title":"Week 6","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"25"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"34.1","spread":"2.3"},{"groupId":"OG001","value":"32.8","spread":"11.8"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"25"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"35.8","spread":"13.0"},{"groupId":"OG001","value":"34.5","spread":"11.5"}]}]},{"title":"Week 18","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"23"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"36.1","spread":"11.9"},{"groupId":"OG001","value":"35.2","spread":"10.2"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"35.2","spread":"13.3"},{"groupId":"OG001","value":"35.0","spread":"11.1"}]}]}]},{"type":"SECONDARY","title":"Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score","description":"The MATRICS Consensus Cognitive Battery (MCCB) measures cognition relevant to schizophrenia and related disorders. The MCCB consists of ten individually administered tests that measure cognitive performance in seven domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores from the ten tests are entered in the MCCB Computer Scoring Program software, which provides an age and gender-corrected T-score and percentile on the seven cognitive domains. A T-score of 50 +/- 10 represents a normative mean performance in each test. Accordingly, the criterion for assignment to cognitively normal-range group require an overall composite T-score from 40 to 60. These data points from baseline visit to week 24 will measure changes in cognition in addition overall cognitive ability compared to healthy individuals.","populationDescription":"12 subjects in experimental arm withdrew or were lost to follow-up by week 24. 4 subjects in the experimental arm were removed from study by investigator by week 24.\n\n11 subjects in placebo arm withdrew or were lost to follow-up by week 24. 2 subjects in the placebo arm were removed from study by investigator by week 24.\n\nReasons for removal include inpatient hospitalization, increase in depressive symptoms, elevated HbA1c, starting insulin and repeatedly missing visits during study period.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Week 6, Week 12, Week 18, and Week 24.","groups":[{"id":"OG000","title":"Experimental","description":"(existing treatment) + (Drug)\n\nIntervention:\n\nDrug: Exenatide\n\nExenatide: Exenatide IM 2mg/week for 24 weeks."},{"id":"OG001","title":"Placebo","description":"(existing treatment) + (Placebo)\n\nIntervention:\n\nDrug: Placebo\n\nPlacebo: Placebo IM for 24 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"35"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"35"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"26.9","spread":"17.2"},{"groupId":"OG001","value":"24.7","spread":"12.6"}]}]},{"title":"Week 6","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"25"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"27.3","spread":"17.3"},{"groupId":"OG001","value":"27.2","spread":"15.4"}]}]},{"title":"Week 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disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":2,"numAtRisk":35}]},{"term":"Suicidal Ideation","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":3,"numAtRisk":35}]},{"term":"Decreased appetite","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":1,"numAtRisk":35}]},{"term":"Sedation","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":1,"numAtRisk":35}]},{"term":"Blurry vision","organSystem":"Eye disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35},{"groupId":"EG001","numAffected":0,"numAtRisk":35}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Xiaoduo Fan, MD, MPH","organization":"UMass Medical School","email":"xiaoduo.fan@umassmed.edu","phone":"(508) 856 -3881"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2019-11-30","uploadDate":"2021-11-30T15:38","filename":"Prot_002.pdf","size":369898},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis 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