{"protocolSection":{"identificationModule":{"nctId":"NCT01608295","orgStudyIdInfo":{"id":"VII-IT-02"},"organization":{"fullName":"University of California, Los Angeles","class":"OTHER"},"briefTitle":"Vilazodone for Treatment of Geriatric Depression","officialTitle":"A Pilot Study of Double-blind Comparison of Vilazodone to Paroxetine in Geriatric Depression"},"statusModule":{"statusVerifiedDate":"2018-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-07"},"primaryCompletionDateStruct":{"date":"2015-09","type":"ACTUAL"},"completionDateStruct":{"date":"2015-09","type":"ACTUAL"},"studyFirstSubmitDate":"2012-05-25","studyFirstSubmitQcDate":"2012-05-25","studyFirstPostDateStruct":{"date":"2012-05-31","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-02-01","resultsFirstSubmitQcDate":"2017-03-28","resultsFirstPostDateStruct":{"date":"2017-05-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-04-12","lastUpdatePostDateStruct":{"date":"2018-05-11","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Helen Lavretsky, MD","investigatorTitle":"Professor","investigatorAffiliation":"University of California, Los Angeles"},"leadSponsor":{"name":"University of California, Los Angeles","class":"OTHER"},"collaborators":[{"name":"Forest Laboratories","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to examine the effects of vilazodone for the treatment of depression in older adults.","detailedDescription":"This is a 12-week double-blind comparison of a novel antidepressant, vilazodone, to the gold-standard drug, paroxetine, for the treatment of geriatric depression. We are interested in assessing the difference in response to vilazodone (VLZ) compared to paroxetine (PAR). We hope to detect difference in response in primary outcomes (depressed mood) and secondary outcomes cognition. We are seeking to examine this directly in 80 older adults (60 years of age or older) with major depression with anticipated 60 completers. This proposed trial will serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and use this project for dose-finding in this population."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["depressed","geriatric","older adults","antidepressants","depression","anxious","major depressive disorder","MDD"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":65,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Vilazodone; Viibryd","type":"EXPERIMENTAL","description":"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.","interventionNames":["Drug: Vilazodone; Viibryd"]},{"label":"Paroxetine; Paxil","type":"EXPERIMENTAL","description":"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.","interventionNames":["Drug: Paroxetine; Paxil"]}],"interventions":[{"type":"DRUG","name":"Vilazodone; Viibryd","description":"Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.","armGroupLabels":["Vilazodone; Viibryd"],"otherNames":["Vilazodone","Viibryd","Antidepressant"]},{"type":"DRUG","name":"Paroxetine; Paxil","description":"Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety.","armGroupLabels":["Paroxetine; Paxil"],"otherNames":["Paroxetine","Paxil","Antidepressant"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Hamilton Depression Rating Scale (HDRS)","description":"The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.","timeFrame":"Baseline and 12 weeks"}],"secondaryOutcomes":[{"measure":"UKU Side-effect Profile","description":"Number of participants with each side-effect event.","timeFrame":"Each visit for 12 weeks"},{"measure":"Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test","description":"The The Rey-Osterrieth Complex Figure Test (REY-O) is a neuropsychological assessment in which measures visual perception and long-term visual memory. Total raw scores range from 0 to 36 with higher scores representing better outcomes in recall. The total raw score represents a sum of subscales scored by 18 individual elements which are scored for both distortion and placement. Two points are awarded to elements that are accurately drawn and properly placed, one point is given to distorted or misplaced elements, 0.5 points are given if an element is both distorted and misplaced, and missing or unrecognizable elements receive zero points.","timeFrame":"Baseline and Final Visit"},{"measure":"Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)","description":"Gene expression data were quantile-normalized and log2-transformed in RNA expression units. The measure included the promoter transcription factor binding motif prevalence ratio of the unit (log2 Vilazodone/Paroxetine) and ranging from a minimum of -3 to a maximum of 3 with higher scores indicating better outcomes.","timeFrame":"Baseline and Final Visit"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 60 years of age or older\n* The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria\n* A 24-item Hamilton Depression Rating Scale (HAMD) score of 17 or higher at baseline\n* Mini-Mental State Exam (MMSE) score \\> 24.\n\nExclusion Criteria:\n\n* Subjects will be excluded if they had any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or recent unstable medical or neurological disorders; any disabilities preventing their participation in the study; diagnosis of mild cognitive impairment (MCI)/dementia; those with known allergic reactions to paroxetine or vilazodone.","healthyVolunteers":false,"sex":"ALL","minimumAge":"60 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Helen Lavretsky, M.D.","affiliation":"University of California, Los Angeles","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"UCLA Semel Institute","city":"Los Angeles","state":"California","zip":"90095","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Double-blind comparison of vilazodone to paroxetine in geriatric depression","url":"http://www.semel.ucla.edu/latelife"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"208 volunteers were assessed for eligibility, of which 100 declined to participate and 37 did not meet inclusion criteria. Seventy-one persons consented to participate, of which 65 passed screening and were enrolled; nine of 65 enrolled participants withdrew before randomization.","recruitmentDetails":"Single site outpatient clinic in the U.S.","groups":[{"id":"FG000","title":"Vilazodone; Viibryd","description":"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.\n\nVilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."},{"id":"FG001","title":"Paroxetine; Paxil","description":"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.\n\nParoxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"25"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Vilazodone; Viibryd","description":"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.\n\nVilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."},{"id":"BG001","title":"Paroxetine; Paxil","description":"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.\n\nParoxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"56"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"14"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"42"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"71.5","spread":"7.2"},{"groupId":"BG001","value":"71.5","spread":"7.7"},{"groupId":"BG002","value":"71.5","spread":"7.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"26"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"30"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"56"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Hamilton Depression Rating Scale (HDRS)","description":"The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and 12 weeks","groups":[{"id":"OG000","title":"Vilazodone; Viibryd","description":"Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."},{"id":"OG001","title":"Paroxetine; Paxil","description":"Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"HDRS Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"17.2","spread":"3.7"},{"groupId":"OG001","value":"16.6","spread":"4.1"}]}]},{"title":"HDRS Final Visit","categories":[{"measurements":[{"groupId":"OG000","value":"7.6","spread":"4.8"},{"groupId":"OG001","value":"7.5","spread":"5.9"}]}]}]},{"type":"SECONDARY","title":"UKU Side-effect Profile","description":"Number of participants with each side-effect event.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Each visit for 12 weeks","groups":[{"id":"OG000","title":"Vilazodone; Viibryd","description":"Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."},{"id":"OG001","title":"Paroxetine; Paxil","description":"Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"Concentration Difficulties","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}]},{"title":"Sedation","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}]},{"title":"Increased dream activity","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]}]},{"title":"Reduced salivation","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}]},{"title":"Diarrhea","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}]},{"title":"Constipation","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"}]}]},{"title":"Orthostatic dizziness","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"SECONDARY","title":"Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test","description":"The The Rey-Osterrieth Complex Figure Test (REY-O) is a neuropsychological assessment in which measures visual perception and long-term visual memory. Total raw scores range from 0 to 36 with higher scores representing better outcomes in recall. The total raw score represents a sum of subscales scored by 18 individual elements which are scored for both distortion and placement. Two points are awarded to elements that are accurately drawn and properly placed, one point is given to distorted or misplaced elements, 0.5 points are given if an element is both distorted and misplaced, and missing or unrecognizable elements receive zero points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and Final Visit","groups":[{"id":"OG000","title":"Vilazodone; Viibryd","description":"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.\n\nVilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."},{"id":"OG001","title":"Paroxetine; Paxil","description":"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.\n\nParoxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"25"}]}],"classes":[{"title":"REY-O 3 Minute Delay Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"13.3","spread":"5.9"},{"groupId":"OG001","value":"13.3","spread":"5.3"}]}]},{"title":"REY-O 3 Minute Delay Final Visit","categories":[{"measurements":[{"groupId":"OG000","value":"15.2","spread":"7.4"},{"groupId":"OG001","value":"16.3","spread":"4.8"}]}]}]},{"type":"SECONDARY","title":"Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)","description":"Gene expression data were quantile-normalized and log2-transformed in RNA expression units. The measure included the promoter transcription factor binding motif prevalence ratio of the unit (log2 Vilazodone/Paroxetine) and ranging from a minimum of -3 to a maximum of 3 with higher scores indicating better outcomes.","populationDescription":"The Arms/Groups are not combined, but results are presented as a ratio of Vilazodone/Paroxetine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"RNA expression units","timeFrame":"Baseline and Final Visit","groups":[{"id":"OG000","title":"Vilazodone and Paroxetine","description":"Subjects randomized to receive vilazodone relative to subjects randomized to receive paroxetine."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"}]}],"classes":[{"title":"AP-1, Activator Protein","categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"0.5"}]}]},{"title":"NF-kB, Nuclear Factor Kappa B","categories":[{"measurements":[{"groupId":"OG000","value":"-1.25","spread":"0.5"}]}]},{"title":"GR, Glucocorticoid Receptor","categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"0.6"}]}]},{"title":"CREB, cAMP response element binding protein","categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"0.7"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Vilazodone; Viibryd","description":"Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.","seriousNumAffected":0,"seriousNumAtRisk":26,"otherNumAffected":19,"otherNumAtRisk":26},{"id":"EG001","title":"Paroxetine; Paxil","description":"Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.","seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":16,"otherNumAtRisk":30}],"otherEvents":[{"term":"Reduced salivation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26},{"groupId":"EG001","numAffected":1,"numAtRisk":30}]},{"term":"Concentration Difficulties","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26},{"groupId":"EG001","numAffected":0,"numAtRisk":30}]},{"term":"Sedation","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26},{"groupId":"EG001","numAffected":3,"numAtRisk":30}]},{"term":"Increased Dream Activity","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26},{"groupId":"EG001","numAffected":3,"numAtRisk":30}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26},{"groupId":"EG001","numAffected":1,"numAtRisk":30}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26},{"groupId":"EG001","numAffected":5,"numAtRisk":30}]},{"term":"Orthostatic dizziness","organSystem":"Vascular disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26},{"groupId":"EG001","numAffected":3,"numAtRisk":30}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Helen Lavretsky, M.D.","organization":"UCLA","email":"hlavretsky@mednet.ucla.edu","phone":"310-794-4619"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003244","term":"Consciousness Disorders"},{"id":"D003863","term":"Depression"},{"id":"D001008","term":"Anxiety Disorders"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D019954","term":"Neurobehavioral Manifestations"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D019965","term":"Neurocognitive Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069503","term":"Vilazodone Hydrochloride"},{"id":"D000928","term":"Antidepressive Agents"},{"id":"D017374","term":"Paroxetine"}],"ancestors":[{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D001572","term":"Benzofurans"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D007211","term":"Indoles"},{"id":"D011619","term":"Psychotropic Drugs"},{"id":"D002491","term":"Central Nervous System Agents"},{"id":"D045506","term":"Therapeutic Uses"},{"id":"D020228","term":"Pharmacologic Actions"},{"id":"D020164","term":"Chemical Actions and Uses"},{"id":"D010880","term":"Piperidines"}]}},"hasResults":true}