{"protocolSection":{"identificationModule":{"nctId":"NCT03924323","orgStudyIdInfo":{"id":"SCT-MD-60"},"organization":{"fullName":"AbbVie","class":"INDUSTRY"},"briefTitle":"A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder","officialTitle":"A Randomized, Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder"},"statusModule":{"statusVerifiedDate":"2022-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-05-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-09-20","type":"ACTUAL"},"completionDateStruct":{"date":"2021-09-20","type":"ACTUAL"},"studyFirstSubmitDate":"2019-04-19","studyFirstSubmitQcDate":"2019-04-19","studyFirstPostDateStruct":{"date":"2019-04-23","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-09-20","resultsFirstSubmitQcDate":"2022-10-21","resultsFirstPostDateStruct":{"date":"2022-11-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-10-21","lastUpdatePostDateStruct":{"date":"2022-11-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AbbVie","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder (GAD) and evaluated using standard questionnaires as having at least moderate severity of GAD. Participating minors will be assigned to receive either the study drug escitalopram or a pill without any drug in it called a placebo. The purpose of this research is to study the safety and effectiveness of escitalopram in minors with GAD."},"conditionsModule":{"conditions":["Anxiety Disorders,Generalized Anxiety Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":273,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram 10 mg/day","type":"EXPERIMENTAL","description":"Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion","interventionNames":["Drug: Escitalopram"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Matching oral administration of placebo once daily","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"8-weeks of treatment followed by 1-week taper down period","armGroupLabels":["Escitalopram 10 mg/day"]},{"type":"OTHER","name":"Placebo","description":"Matching oral administration of inactive substance once daily","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Pediatric Anxiety Rating Scale (PARS) Severity Score","description":"The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders including generalized anxiety disorder (GAD) in children. The PARS severity score for GAD will be assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7) each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.","timeFrame":"Baseline to Week 8"}],"secondaryOutcomes":[{"measure":"Response Rate on the PARS","description":"Response is defined as a 50% improvement on the PARS severity score for GAD","timeFrame":"Week 8"},{"measure":"Remission Rate on the PARS","description":"Remission is defined as PARS severity score for GAD ≤8 (using 6 PARS items: 2, 3, 4, 5, 6, and 7)","timeFrame":"Week 8"},{"measure":"Change on the Clinical Global Impression of Severity (CGI-S)","description":"Remission rate on CGI-S at acute treatment endpoint (Week 8). Remission rate is defined as the percentage of subjects having a CGI-S score ≤2 at endpoint. CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.","timeFrame":"Week 8"},{"measure":"Change on the Children's Global Assessment Scale (CGAS)","description":"Remission rate on the CGAS at acute treatment endpoint (Week 8). Functional remission is defined as CGAS \\>70. The CGAS used is a 100-point scale ranging from 1 to 100, with higher scores indicating better functioning.","timeFrame":"Week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Subject's parent/legal representative must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.\n* Subject meets DSM-5 criteria for a primary diagnosis of GAD at screening established by a comprehensive psychiatric evaluation and confirmed/supported using the Mini-International Neuropsychiatric Interview for children and adolescents (MINI Kid).\n* Male subjects who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug.\n* Female subjects who are sexually active and are of childbearing potential must use, with their partner, an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug.\n* Female subjects who are not of childbearing potential do not need to use any methods of contraception. This includes preadolescent and adolescent females who have not reached menarche. - Subject must have venous access enough to allow blood sampling and be compliant with blood draws as per the protocol.\n\nExclusion Criteria:\n\n* Current diagnosis of MDD, attention-deficit/hyperactivity disorder, or lifetime diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, feeding and/or eating disorder, obsessive-compulsive disorder, conduct disorder, oppositional defiant disorder, post-traumatic stress disorder, panic disorder, or pervasive development disorder.\n* Suspected or previously diagnosed intellectual disability disorder.\n* One or more first-degree relatives with diagnosed bipolar I disorder.\n* History of seizure disorder (other than febrile seizures).\n* History of electroconvulsive therapy at any time during the subject's lifetime.\n* Known hypersensitivity to escitalopram (escitalopram oxalate) or citalopram or any of the inactive ingredients or had frequent or severe allergic reactions to multiple medications.\n* Taking any medications that are contraindicated to escitalopram (escitalopram oxalate).\n* Inability to speak, read, or understand English well enough to complete the assessments.\n* No active suicidal ideation or lifetime history of suicidal behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).","healthyVolunteers":false,"sex":"ALL","minimumAge":"7 Years","maximumAge":"17 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"ALLERGAN INC.","affiliation":"Allergan","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Harmonex /ID# 233342","city":"Dothan","state":"Alabama","zip":"36303","country":"United States","geoPoint":{"lat":31.22323,"lon":-85.39049}},{"facility":"Woodland International Research Group /ID# 233348","city":"Little Rock","state":"Arkansas","zip":"72211","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"facility":"Woodland Research Northwest, LLC /ID# 233366","city":"Rogers","state":"Arkansas","zip":"72758-6442","country":"United States","geoPoint":{"lat":36.33202,"lon":-94.11854}},{"facility":"ATP Clinical Research, Inc /ID# 233362","city":"Costa Mesa","state":"California","zip":"92626-4607","country":"United States","geoPoint":{"lat":33.64113,"lon":-117.91867}},{"facility":"ProScience Research Group /ID# 233374","city":"Culver City","state":"California","zip":"90230-6632","country":"United States","geoPoint":{"lat":34.02112,"lon":-118.39647}},{"facility":"Sun Valley Research Center /ID# 233343","city":"Imperial","state":"California","zip":"92251-9401","country":"United States","geoPoint":{"lat":32.84755,"lon":-115.56944}},{"facility":"MCB Clinical Research Centers /ID# 233372","city":"Colorado Springs","state":"Colorado","zip":"80910","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"Emerson Clinical Research Inst /ID# 233371","city":"Washington D.C.","state":"District of Columbia","zip":"20011","country":"United States","geoPoint":{"lat":38.89511,"lon":-77.03637}},{"facility":"Innovative Clinical Research /ID# 233365","city":"Fort Lauderdale","state":"Florida","zip":"33319","country":"United States","geoPoint":{"lat":26.12231,"lon":-80.14338}},{"facility":"Indago Research and Health Cen /ID# 233364","city":"Hialeah","state":"Florida","zip":"33012-4170","country":"United States","geoPoint":{"lat":25.8576,"lon":-80.27811}},{"facility":"CNS Healthcare - Jacksonville /ID# 233352","city":"Jacksonville","state":"Florida","zip":"32256-6039","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Accel Research Sites-Maitland Clinical Research Unit /ID# 233368","city":"Maitland","state":"Florida","zip":"32751","country":"United States","geoPoint":{"lat":28.62778,"lon":-81.36312}},{"facility":"Medical Research Group of Central Florida /ID# 233357","city":"Orange City","state":"Florida","zip":"32763","country":"United States","geoPoint":{"lat":28.94888,"lon":-81.29867}},{"facility":"Clinical Neuroscience Solutions, Inc /ID# 233350","city":"Orlando","state":"Florida","zip":"32801-2986","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"APG Research, LLC /ID# 233337","city":"Orlando","state":"Florida","zip":"32803","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"University of South Florida Rothman Center of Neuropsychiatry /ID# 233356","city":"St. Petersburg","state":"Florida","zip":"33701-4708","country":"United States","geoPoint":{"lat":27.77086,"lon":-82.67927}},{"facility":"Capstone Clinical Research /ID# 233354","city":"Libertyville","state":"Illinois","zip":"60048-5341","country":"United States","geoPoint":{"lat":42.28308,"lon":-87.95313}},{"facility":"Baber Research Group /ID# 233363","city":"Naperville","state":"Illinois","zip":"60563-6502","country":"United States","geoPoint":{"lat":41.78586,"lon":-88.14729}},{"facility":"Psychiatric Associates /ID# 233360","city":"Overland Park","state":"Kansas","zip":"66221","country":"United States","geoPoint":{"lat":38.98223,"lon":-94.67079}},{"facility":"Alivation Research /ID# 233338","city":"Lincoln","state":"Nebraska","zip":"68526-9474","country":"United States","geoPoint":{"lat":40.8,"lon":-96.66696}},{"facility":"Center for Psychiatry and Behavioral Medicine Inc /ID# 233355","city":"Las Vegas","state":"Nevada","zip":"89128-0819","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Manhattan Behavioral Medicine PLLC /ID# 233351","city":"New York","state":"New York","zip":"10036","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Finger Lakes Clinical Research /ID# 233347","city":"Rochester","state":"New York","zip":"14618-1609","country":"United 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Chester","state":"Ohio","zip":"45069","country":"United States","geoPoint":{"lat":39.33172,"lon":-84.40716}},{"facility":"SP Research, PLLC /ID# 233340","city":"Oklahoma City","state":"Oklahoma","zip":"73112-8729","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Central States Research /ID# 233339","city":"Tulsa","state":"Oklahoma","zip":"74136","country":"United States","geoPoint":{"lat":36.15398,"lon":-95.99277}},{"facility":"Coastal Carolina Research Center /ID# 233344","city":"North Charleston","state":"South Carolina","zip":"29405","country":"United States","geoPoint":{"lat":32.85462,"lon":-79.97481}},{"facility":"Houston Clinical Trials /ID# 233345","city":"Bellaire","state":"Texas","zip":"77401-2928","country":"United States","geoPoint":{"lat":29.70579,"lon":-95.45883}},{"facility":"Relaro Medical Trials /ID# 233369","city":"Dallas","state":"Texas","zip":"75243","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"AIM Trials /ID# 233361","city":"Plano","state":"Texas","zip":"75093","country":"United States","geoPoint":{"lat":33.01984,"lon":-96.69889}},{"facility":"Focus Center, PC /ID# 233349","city":"Ogden","state":"Utah","zip":"84405-4946","country":"United States","geoPoint":{"lat":41.223,"lon":-111.97383}},{"facility":"University of Virginia /ID# 233370","city":"Charlottesville","state":"Virginia","zip":"22903","country":"United States","geoPoint":{"lat":38.02931,"lon":-78.47668}},{"facility":"Northwest Clinical Research Center /ID# 233358","city":"Bellevue","state":"Washington","zip":"98007","country":"United States","geoPoint":{"lat":47.61038,"lon":-122.20068}},{"facility":"Core Clinical Research /ID# 233353","city":"Everett","state":"Washington","zip":"98201","country":"United States","geoPoint":{"lat":47.97898,"lon":-122.20208}}]},"referencesModule":{"references":[{"pmid":"37074330","type":"DERIVED","citation":"Strawn JR, Moldauer L, Hahn RD, Wise A, Bertzos K, Eisenberg B, Greenberg E, Liu C, Gopalkrishnan M, McVoy M, Knutson JA. A Multicenter Double-Blind, Placebo-Controlled Trial of Escitalopram in Children and Adolescents with Generalized Anxiety Disorder. J Child Adolesc Psychopharmacol. 2023 Apr;33(3):91-100. doi: 10.1089/cap.2023.0004."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/","accessCriteria":"Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/","url":"https://vivli.org/ourmember/abbvie/"}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"273 participants are included in the Safety Population with 136 participants being randomized to the Placebo group and 137 participants randomized to the Escitalopram group","groups":[{"id":"FG000","title":"Placebo","description":"Matching oral administration of placebo once daily\n\nPlacebo: Matching oral administration of inactive substance once daily"},{"id":"FG001","title":"Escitalopram 10 mg/Day","description":"Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion\n\nEscitalopram: 8-weeks of treatment followed by 1-week taper down period"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"136"},{"groupId":"FG001","numSubjects":"137"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"117"},{"groupId":"FG001","numSubjects":"123"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"14"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The Safety Population consisted of all subjects in the Randomized Population who took at least 1 dose of study medication.","groups":[{"id":"BG000","title":"Placebo","description":"Matching oral administration of placebo once daily\n\nPlacebo: Matching oral administration of inactive substance once daily"},{"id":"BG001","title":"Escitalopram 10 mg/Day","description":"Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion\n\nEscitalopram: 8-weeks of treatment followed by 1-week taper down period"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"136"},{"groupId":"BG001","value":"137"},{"groupId":"BG002","value":"273"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12.4","spread":"2.6"},{"groupId":"BG001","value":"12.7","spread":"2.7"},{"groupId":"BG002","value":"12.6","spread":"2.6"}]}]}]},{"title":"Age, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"7 Years to 11 Years","categories":[{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"89"}]}]},{"title":"12 Years to 17 years","categories":[{"measurements":[{"groupId":"BG000","value":"91"},{"groupId":"BG001","value":"93"},{"groupId":"BG002","value":"184"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"93"},{"groupId":"BG001","value":"94"},{"groupId":"BG002","value":"187"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"43"},{"groupId":"BG002","value":"86"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"53"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"114"},{"groupId":"BG001","value":"106"},{"groupId":"BG002","value":"220"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"6"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"28"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"110"},{"groupId":"BG001","value":"113"},{"groupId":"BG002","value":"223"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"10"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Pediatric Anxiety Rating Scale (PARS) Severity Score","description":"The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders including generalized anxiety disorder (GAD) in children. The PARS severity score for GAD will be assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7) each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.","populationDescription":"The modified Intent-to-treat (mITT) Population was defined as all subjects who were randomized and received at least 1 dose of study medication and had both baseline and at least 1 post-baseline primary efficacy measure (ie, PARS severity score).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline to Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Matching oral administration of placebo once daily\n\nPlacebo: Matching oral administration of inactive substance once daily"},{"id":"OG001","title":"Escitalopram 10 mg/Day","description":"Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion\n\nEscitalopram: 8-weeks of treatment followed by 1-week taper down period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"124"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.38","spread":"0.494"},{"groupId":"OG001","value":"-7.81","spread":"0.484"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0281","statisticalMethod":"mixed-effects model for repeated measure","paramType":"least squares mean difference","paramValue":"-1.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.69","ciUpperLimit":"-0.15"}]},{"type":"SECONDARY","title":"Response Rate on the PARS","description":"Response is defined as a 50% improvement on the PARS severity score for GAD","populationDescription":"The modified Intent-to-treat (mITT) Population was defined as all subjects who were randomized and received at least 1 dose of study medication and had both baseline and at least 1 post-baseline primary efficacy measure (ie, PARS severity score).","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Matching oral administration of placebo once daily\n\nPlacebo: Matching oral administration of inactive substance once daily"},{"id":"OG001","title":"Escitalopram 10 mg/Day","description":"Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion\n\nEscitalopram: 8-weeks of treatment followed by 1-week taper down period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"124"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"49"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4521","statisticalMethod":"generalized linear mixed model (GLMMIX)","paramType":"Odds Ratio (OR)","paramValue":"1.253","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.695","ciUpperLimit":"2.258"}]},{"type":"SECONDARY","title":"Remission Rate on the PARS","description":"Remission is defined as PARS severity score for GAD ≤8 (using 6 PARS items: 2, 3, 4, 5, 6, and 7)","populationDescription":"The modified Intent-to-treat (mITT) Population was defined as all subjects who were randomized and received at least 1 dose of study medication and had both baseline and at least 1 post-baseline primary efficacy measure (ie, PARS severity score).","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Matching oral administration of placebo once daily\n\nPlacebo: Matching oral administration of inactive substance once daily"},{"id":"OG001","title":"Escitalopram 10 mg/Day","description":"Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion\n\nEscitalopram: 8-weeks of treatment followed by 1-week taper down period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"124"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"22"}]}]}],"analyses":[{"groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6928","statisticalMethod":"generalized linear mixed model (GLMMIX)","paramType":"Odds Ratio (OR)","paramValue":"1.157","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.560","ciUpperLimit":"2.387"}]},{"type":"SECONDARY","title":"Change on the Clinical Global Impression of Severity (CGI-S)","description":"Remission rate on CGI-S at acute treatment endpoint (Week 8). Remission rate is defined as the percentage of subjects having a CGI-S score ≤2 at endpoint. CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.","populationDescription":"The modified Intent-to-treat (mITT) Population was defined as all subjects who were randomized and received at least 1 dose of study medication and had both baseline and at least 1 post-baseline primary efficacy measure (ie, PARS severity score).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Matching oral administration of placebo once daily\n\nPlacebo: Matching oral administration of inactive substance once daily"},{"id":"OG001","title":"Escitalopram 10 mg/Day","description":"Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion\n\nEscitalopram: 8-weeks of treatment followed by 1-week taper down period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"124"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"1.1"},{"groupId":"OG001","value":"-1.3","spread":"1.0"}]}]}]},{"type":"SECONDARY","title":"Change on the Children's Global Assessment Scale (CGAS)","description":"Remission rate on the CGAS at acute treatment endpoint (Week 8). Functional remission is defined as CGAS \\>70. 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