{"protocolSection":{"identificationModule":{"nctId":"NCT00107120","orgStudyIdInfo":{"id":"SCT-MD-32"},"organization":{"fullName":"Forest Laboratories","class":"INDUSTRY"},"briefTitle":"The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder","officialTitle":"A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2012-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-03"},"primaryCompletionDateStruct":{"date":"2007-05","type":"ACTUAL"},"studyFirstSubmitDate":"2005-04-05","studyFirstSubmitQcDate":"2005-04-05","studyFirstPostDateStruct":{"date":"2005-04-06","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-04-21","resultsFirstSubmitQcDate":"2009-09-25","resultsFirstPostDateStruct":{"date":"2009-11-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-04-04","lastUpdatePostDateStruct":{"date":"2012-04-06","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Forest Laboratories","class":"INDUSTRY"}},"descriptionModule":{"briefSummary":"Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Major Depressive Disorder","Depression","Adolescents","Escitalopram","Pediatrics"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":312,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"EXPERIMENTAL","description":"Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks","interventionNames":["Drug: Escitalopram"]},{"label":"2","type":"PLACEBO_COMPARATOR","description":"Placebo once daily for up to 8 weeks","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks","armGroupLabels":["Escitalopram"],"otherNames":["Lexapro (TM)"]},{"type":"DRUG","name":"Placebo","description":"Placebo once daily for up to 8 weeks","armGroupLabels":["2"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score","description":"Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.","timeFrame":"Baseline to end of week 8"}],"secondaryOutcomes":[{"measure":"Clinical Global Impressions - Improvement","description":"Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse).","timeFrame":"CGI-I score at the end of Week 8"}],"otherOutcomes":[{"measure":"Children's Global Assessment Scale","description":"Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest).","timeFrame":"At baseline and end of week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.\n* Patient's current depressive episode must be at least 12 weeks in duration\n* Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.\n\nExclusion Criteria:\n\n* Patients who currently meet DSM-IV criteria for:\n\n  1. attention deficit-hyperactivity disorder\n  2. obsessive-compulsive disorder\n  3. posttraumatic stress disorder\n  4. bipolar disorder\n  5. pervasive developmental disorder\n  6. mental retardation\n  7. conduct disorder\n  8. oppositional defiant disorder\n* Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.","healthyVolunteers":false,"sex":"ALL","minimumAge":"12 Years","maximumAge":"17 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Daniel Ventura, PhD","affiliation":"Forest Research Institute, a subsidiary of Forest Laboratories, Inc.","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"University of California at Davis, MIND Institute, Health Services","city":"Sacramento","state":"California","zip":"95817","country":"United States","geoPoint":{"lat":38.58157,"lon":-121.4944}},{"facility":"UCSD Outpatient Psychiatry Services","city":"San Diego","state":"California","zip":"92103","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"PCSD - Feighner Research","city":"San Diego","state":"California","zip":"92111","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Children's National Medical Center","city":"Washington D.C.","state":"District of Columbia","zip":"20010","country":"United States","geoPoint":{"lat":38.89511,"lon":-77.03637}},{"facility":"University of Florida - Child Study Program","city":"Gainesville","state":"Florida","zip":"32610","country":"United States","geoPoint":{"lat":29.65163,"lon":-82.32483}},{"facility":"Clinical Neuroscience Solutions, Inc.","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Janus Center for Psychiatric Research","city":"West Palm Beach","state":"Florida","zip":"33407","country":"United States","geoPoint":{"lat":26.71534,"lon":-80.05337}},{"facility":"Kolin Research Group","city":"Winter Park","state":"Florida","zip":"32789","country":"United States","geoPoint":{"lat":28.6,"lon":-81.33924}},{"facility":"Capstone Clinical Research","city":"Libertyville","state":"Illinois","zip":"60048","country":"United States","geoPoint":{"lat":42.28308,"lon":-87.95313}},{"facility":"Clinco","city":"Terre Haute","state":"Indiana","zip":"47802","country":"United States","geoPoint":{"lat":39.4667,"lon":-87.41391}},{"facility":"Psychiatric Associates","city":"Overland","state":"Kansas","zip":"66211","country":"United States"},{"facility":"Pharmasite Research, Inc.","city":"Baltimore","state":"Maryland","zip":"21208","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"Capitol Clinical Research Associates","city":"Rockville","state":"Maryland","zip":"20852","country":"United States","geoPoint":{"lat":39.084,"lon":-77.15276}},{"facility":"St. Charles Psychiatric Associates","city":"Saint Charles","state":"Missouri","zip":"63301","country":"United States","geoPoint":{"lat":38.78394,"lon":-90.48123}},{"facility":"Creighton University Medical School, Department of Psychiatry","city":"Omaha","state":"Nebraska","zip":"68131","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"CNS Research Institute","city":"Clementon","state":"New Jersey","zip":"08021","country":"United States","geoPoint":{"lat":39.8115,"lon":-74.98294}},{"facility":"Pulmonary and Allergy Associates, P. A.","city":"Summit","state":"New Jersey","zip":"07901","country":"United States","geoPoint":{"lat":40.71562,"lon":-74.36468}},{"facility":"North Carolina Neuropsychiatry, PA","city":"Chapel Hill","state":"North Carolina","zip":"27514","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}},{"facility":"University of Cincinnati College of Medicine, Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","zip":"45229","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry","city":"Cleveland","state":"Ohio","zip":"44106","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}},{"facility":"IPS Research Company","city":"Oklahoma City","state":"Oklahoma","zip":"73103","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section","city":"Philadelphia","state":"Pennsylvania","zip":"19104","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Drexel University College of Medicine, Friends Hospital","city":"Philadelphia","state":"Pennsylvania","zip":"19124","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Clinical Neuroscience Solutions","city":"Memphis","state":"Tennessee","zip":"38119","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"University of Texas Southwestern Medical Center, Center for Pediatric Psychiatry","city":"Dallas","state":"Texas","zip":"75235","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences","city":"Galveston","state":"Texas","zip":"77555","country":"United States","geoPoint":{"lat":29.30135,"lon":-94.7977}},{"facility":"Brighton Research Group, LLC","city":"Virginia Beach","state":"Virginia","zip":"23452","country":"United States","geoPoint":{"lat":36.85293,"lon":-75.97799}},{"facility":"Northwest Clinical Research Center","city":"Bellevue","state":"Washington","zip":"98004","country":"United States","geoPoint":{"lat":47.61038,"lon":-122.20068}}]},"referencesModule":{"references":[{"pmid":"19465881","type":"RESULT","citation":"Emslie GJ, Ventura D, Korotzer A, Tourkodimitris S. Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. J Am Acad Child Adolesc Psychiatry. 2009 Jul;48(7):721-729. doi: 10.1097/CHI.0b013e3181a2b304."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"2 week screening with one-week single-blind placebo. Patients meeting selection criteria at baseline were randomized to once daily escitalopram 10-20mg/day or placebo (1:1).","recruitmentDetails":"Recruitment period was from April 1, 2005 through March, 2007 at 40 centers in the US.","groups":[{"id":"FG000","title":"Escitalopram","description":"Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability."},{"id":"FG001","title":"Placebo","description":"Once daily oral administration of placebo tablets"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Safety Population defined as all patients who took at least one dose of double-blind study drug","numSubjects":"155"},{"groupId":"FG001","comment":"Safety Population defined as all patients who took at least one dose of double-blind study drug","numSubjects":"157"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"126"},{"groupId":"FG001","numSubjects":"133"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"24"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"moving away from site","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"death of parent","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram","description":"Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability."},{"id":"BG001","title":"Placebo","description":"Once daily oral administration of placebo tablets"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"155"},{"groupId":"BG001","value":"157"},{"groupId":"BG002","value":"312"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"155"},{"groupId":"BG001","value":"157"},{"groupId":"BG002","value":"312"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"14.7","spread":"1.6"},{"groupId":"BG001","value":"14.5","spread":"1.5"},{"groupId":"BG002","value":"14.6","spread":"1.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"184"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"65"},{"groupId":"BG002","value":"128"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"155"},{"groupId":"BG001","value":"157"},{"groupId":"BG002","value":"312"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score","description":"Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.","populationDescription":"Efficacy analyses used Intent-To-Treat Population, which consisted of all patients who received at least 1 dose of double-blind study drug \\& who had at least 1 post-baseline assessment of the CDRS-R. LOCF technique was used to impute missing data. 1 escitalopram pt. did not have a post-baseline CDRS-R total score.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-04","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in total score at endpoint","timeFrame":"Baseline to end of week 8","groups":[{"id":"OG000","title":"Escitalopram","description":"Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability."},{"id":"OG001","title":"Placebo","description":"Once daily oral administration of placebo tablets"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"157"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-22.4","spread":"1.1"},{"groupId":"OG001","value":"-18.4","spread":"1.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The null hypothesis is that there is no difference in the Change from Baseline to Week 8 in CDRS-R total score between treatment groups. The power calculation was based on the change from baseline to Week 8 in CDRS-R total score (LOCF approach). Assuming an effect size (treatment group difference relative to standard deviation) of 0.325, a sample size of approximately 150 patients per treatment group was used to provide at least 80% power at a significance level of 0.05 using a two-sided test.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.022","pValueComment":"Two-sided at 5% level of significance p \\< 0.05 considered significant","statisticalMethod":"ANCOVA","statisticalComment":"The model included study center and treatment as factors and baseline core as covariate","paramType":"Least Square Means Difference","paramValue":"-3.4","ciPctValue":"95","ciLowerLimit":"-6.2","ciUpperLimit":"-0.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.458","estimateComment":"Differences are Escitalopram-Placebo"}]},{"type":"SECONDARY","title":"Clinical Global Impressions - Improvement","description":"Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse).","populationDescription":"The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-04","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Score on scale","timeFrame":"CGI-I score at the end of Week 8","groups":[{"id":"OG000","title":"Escitalopram","description":"Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability."},{"id":"OG001","title":"Placebo","description":"Once daily oral administration of placebo tablets"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"157"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"0.1"},{"groupId":"OG001","value":"2.5","spread":"0.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Missing values were imputed using the LOCF approach.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.008","pValueComment":"Two-sided at 5% level of significance","statisticalMethod":"ANCOVA","statisticalComment":"The model included treatment and center as factors and baseline CGI-Severity score as covariate.","paramType":"Least Square Means Difference","paramValue":"-0.344","ciPctValue":"95","ciLowerLimit":"-0.595","ciUpperLimit":"0.092","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.1128","estimateComment":"Differences are Escitalopram-Placebo"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Children's Global Assessment Scale","description":"Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest).","populationDescription":"The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-04","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Change in score","timeFrame":"At baseline and end of week 8","groups":[{"id":"OG000","title":"Escitalopram","description":"Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability."},{"id":"OG001","title":"Placebo","description":"Once daily oral administration of placebo tablets"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"157"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.7","spread":"1.0"},{"groupId":"OG001","value":"12.4","spread":"1.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"ANCOVA on the Change from Baseline to Week 8 in CGAS score. The model included treatment and center as factors and baseline score as covariate. Missing values were imputed using the LOCF approach.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.103","pValueComment":"Two-sided at 5% level of significance","statisticalMethod":"ANCOVA","paramType":"Least Square Means Difference","paramValue":"2.169","ciPctValue":"95","ciLowerLimit":"-0.439","ciUpperLimit":"4.777","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.324","estimateComment":"Differences are Escitalopram-Placebo"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Escitalopram","description":"Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.","seriousNumAffected":4,"seriousNumAtRisk":155,"otherNumAffected":121,"otherNumAtRisk":155},{"id":"EG001","title":"Placebo","description":"Once daily oral administration of placebo tablets","seriousNumAffected":2,"seriousNumAtRisk":157,"otherNumAffected":118,"otherNumAtRisk":157}],"seriousEvents":[{"term":"Inflicted Injury","organSystem":"General disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":155},{"groupId":"EG001","numAffected":0,"numAtRisk":157}]},{"term":"Irritability","organSystem":"Psychiatric disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":155},{"groupId":"EG001","numAffected":0,"numAtRisk":157}]},{"term":"Suicidal Tendency","organSystem":"Psychiatric disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":155},{"groupId":"EG001","numAffected":1,"numAtRisk":157}]},{"term":"Depression Aggravated","organSystem":"Psychiatric disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":155},{"groupId":"EG001","numAffected":1,"numAtRisk":157}]}],"otherEvents":[{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":155},{"groupId":"EG001","numAffected":40,"numAtRisk":157}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":155},{"groupId":"EG001","numAffected":10,"numAtRisk":157}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":155},{"groupId":"EG001","numAffected":13,"numAtRisk":157}]},{"term":"Abdominal Pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":155},{"groupId":"EG001","numAffected":11,"numAtRisk":157}]},{"term":"Inflicted Injury","organSystem":"General disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":155},{"groupId":"EG001","numAffected":21,"numAtRisk":157}]},{"term":"Pharyngitis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":155},{"groupId":"EG001","numAffected":15,"numAtRisk":157}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":155},{"groupId":"EG001","numAffected":13,"numAtRisk":157}]},{"term":"Influenza-like Symptoms","organSystem":"General disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":155},{"groupId":"EG001","numAffected":5,"numAtRisk":157}]},{"term":"Rhinitis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":155},{"groupId":"EG001","numAffected":14,"numAtRisk":157}]},{"term":"Menstrual Cramps","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":155},{"groupId":"EG001","numAffected":14,"numAtRisk":157}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":155},{"groupId":"EG001","numAffected":9,"numAtRisk":157}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":155},{"groupId":"EG001","numAffected":5,"numAtRisk":157}]},{"term":"Upper Respiratory Tract Infections","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"WHOART v.1998/04","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":155},{"groupId":"EG001","numAffected":12,"numAtRisk":157}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"Sponsor can review results communications prior to public release \\& can embargo communications re: results for 90 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential info. Upon sponsor's request, PI shall delete any proprietary info \\& shall not include raw data in pub. On sponsor's request, PI shall delay submission for any pub while sponsor files patent apps. If trial is multi-center, PI agrees that first publication shall be a multi-center pub."},"pointOfContact":{"title":"Daniel Ventura, PhD","organization":"Forest Research Institute, a subsidiary of Forest Laboratories, Inc.","email":"daniel.ventura@frx.com","phone":"201-427-8252"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009570","term":"Nitriles"},{"id":"D001572","term":"Benzofurans"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}