Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-04-05 @ 5:10 PM
Study NCT ID:
NCT00107120
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2005-04-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'daniel.ventura@frx.com', 'phone': '201-427-8252', 'title': 'Daniel Ventura, PhD', 'organization': 'Forest Research Institute, a subsidiary of Forest Laboratories, Inc.'}, 'certainAgreement': {'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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'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.', 'otherNumAtRisk': 155, 'otherNumAffected': 121, 'seriousNumAtRisk': 155, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Once daily oral administration of placebo tablets', 'otherNumAtRisk': 157, 'otherNumAffected': 118, 'seriousNumAtRisk': 157, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Inflicted Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Influenza-like Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Menstrual Cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 14}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Upper Respiratory Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}], 'seriousEvents': [{'term': 'Inflicted Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Suicidal Tendency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}, {'term': 'Depression Aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHOART v.1998/04'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], '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'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-18.4', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Means Difference', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '-0.5', 'pValueComment': 'Two-sided at 5% level of significance p \\< 0.05 considered significant', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.458', 'estimateComment': 'Differences are Escitalopram-Placebo', '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.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model included study center and treatment as factors and baseline core as covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end of week 8', '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.", 'unitOfMeasure': 'Change in total score at endpoint', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', '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.', 'anticipatedPostingDate': '2009-04'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impressions - Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], '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'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Means Difference', 'ciPctValue': '95', 'paramValue': '-0.344', 'ciLowerLimit': '-0.595', 'ciUpperLimit': '0.092', 'pValueComment': 'Two-sided at 5% level of significance', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1128', 'estimateComment': 'Differences are Escitalopram-Placebo', 'groupDescription': 'Missing values were imputed using the LOCF approach.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model included treatment and center as factors and baseline CGI-Severity score as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'CGI-I score at the end of Week 8', '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).', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.', 'anticipatedPostingDate': '2009-04'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Children's Global Assessment Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], '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'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Means Difference', 'ciPctValue': '95', 'paramValue': '2.169', 'ciLowerLimit': '-0.439', 'ciUpperLimit': '4.777', 'pValueComment': 'Two-sided at 5% level of significance', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.324', 'estimateComment': 'Differences are Escitalopram-Placebo', '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.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and end of week 8', '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).", 'unitOfMeasure': 'Change in score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.', 'anticipatedPostingDate': '2009-04'}]}, 'participantFlowModule': {'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': [{'comment': 'Safety Population defined as all patients who took at least one dose of double-blind study drug', 'groupId': 'FG000', 'numSubjects': '155'}, {'comment': 'Safety Population defined as all patients who took at least one dose of double-blind study drug', 'groupId': 'FG001', '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'}]}]}], 'recruitmentDetails': 'Recruitment period was from April 1, 2005 through March, 2007 at 40 centers in the US.', '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).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}], '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'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '14.5', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '14.6', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'lastUpdateSubmitDate': '2012-04-04', 'studyFirstSubmitDate': '2005-04-05', 'resultsFirstSubmitDate': '2009-04-21', 'studyFirstSubmitQcDate': '2005-04-05', 'lastUpdatePostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-09-25', 'studyFirstPostDateStruct': {'date': '2005-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Children's Global Assessment Scale", 'timeFrame': 'At baseline and end of week 8', '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)."}], 'primaryOutcomes': [{'measure': "Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score", 'timeFrame': 'Baseline to end of week 8', '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."}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impressions - Improvement', 'timeFrame': 'CGI-I score at the end of Week 8', '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).'}]}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Depression', 'Adolescents', 'Escitalopram', 'Pediatrics'], 'conditions': ['Major Depressive Disorder']}, '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.'}]}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, '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."}, 'identificationModule': {'nctId': 'NCT00107120', 'briefTitle': 'The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'SCT-MD-32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Escitalopram', 'description': 'Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks', 'interventionNames': ['Drug: Escitalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo once daily for up to 8 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['Lexapro (TM)'], 'description': 'Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks', 'armGroupLabels': ['Escitalopram']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily for up to 8 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Davis, MIND Institute, Health Services', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Outpatient Psychiatry Services', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'PCSD - Feighner Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Child Study Program', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc.', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Janus Center for Psychiatric Research', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Kolin Research Group', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '60048', 'city': 'Libertyville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Capstone Clinical Research', 'geoPoint': {'lat': 42.28308, 'lon': -87.95313}}, {'zip': '47802', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'Clinco', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'zip': '66211', 'city': 'Overland', 'state': 'Kansas', 'country': 'United States', 'facility': 'Psychiatric Associates'}, {'zip': '21208', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pharmasite Research, Inc.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Capitol Clinical Research Associates', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Charles Psychiatric Associates', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University Medical School, Department of Psychiatry', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08021', 'city': 'Clementon', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CNS Research Institute', 'geoPoint': {'lat': 39.8115, 'lon': -74.98294}}, {'zip': '07901', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Pulmonary and Allergy Associates, P. 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