Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-26 @ 11:54 AM
Study NCT ID:
NCT01372150
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2011-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
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': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.', 'description': 'The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).', 'otherNumAtRisk': 112, 'otherNumAffected': 44, 'seriousNumAtRisk': 112, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fluoxetine', 'description': 'Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).', 'otherNumAtRisk': 112, 'otherNumAffected': 39, 'seriousNumAtRisk': 112, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'DVS SR', 'description': 'DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.', 'otherNumAtRisk': 115, 'otherNumAffected': 47, 'seriousNumAtRisk': 115, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Disinhibition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).'}, {'id': 'OG001', 'title': 'Fluoxetine', 'description': 'Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).'}, {'id': 'OG002', 'title': 'DVS SR', 'description': 'DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.07', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-24.79', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '-22.61', 'spread': '1.17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.226', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '4.48', 'estimateComment': 'Adjusted mean difference = placebo - fluoxetine', 'groupDescription': 'Fluoxetine versus Placebo', 'statisticalMethod': 'Mixed-effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed-effects model for repeated measures (MMRM)'}, {'pValue': '0.739', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-3.23', 'ciUpperLimit': '2.30', 'estimateComment': 'Adjusted mean difference = Placebo - DVS SR', 'groupDescription': 'DVS SR versus Placebo', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': "Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).'}, {'id': 'OG001', 'title': 'Fluoxetine', 'description': 'Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).'}, {'id': 'OG002', 'title': 'DVS SR', 'description': 'DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.71', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-1.88', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-1.70', 'spread': '0.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.224', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.46', 'estimateComment': 'Adjusted mean difference = Placebo - Fluoxetine', 'groupDescription': 'Fluoxetine versus Placebo', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.944', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.27', 'estimateComment': 'Adjusted mean difference = Placebo - DVS SR', 'groupDescription': 'DVS SR versus Placebo', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': "A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).'}, {'id': 'OG001', 'title': 'Fluoxetine', 'description': 'Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).'}, {'id': 'OG002', 'title': 'DVS SR', 'description': 'DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.'}], 'classes': [{'title': 'Week 1, Very Much Improved (n=102, 101, 111)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, Much Improved (n=102, 101, 111)', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, Minimally Improved (n=102, 101, 111)', 'categories': [{'measurements': [{'value': '46.1', 'groupId': 'OG000'}, {'value': '35.6', 'groupId': 'OG001'}, {'value': '43.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, No Change (n=102, 101, 111)', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000'}, {'value': '47.5', 'groupId': 'OG001'}, {'value': '45.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, Minimally Worse (n=102, 101, 111)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, Much Worse (n=102, 101, 111)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, Very Much Worse (n=102, 101, 111)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Very Much Improved (n=103, 105, 110)', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Much Improved (n=103, 105, 110)', 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '31.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Minimally Improved (n=103, 105, 110)', 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '44.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, No Change (n=103, 105, 110)', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}, {'value': '22.9', 'groupId': 'OG001'}, {'value': '19.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Minimally Worse (n=103, 105, 110)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Much Worse (n=103, 105, 110)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Very Much Worse (n=103, 105, 110)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Very Much Improved (n=105, 102, 107)', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}, {'value': '7.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Much Improved (n=105, 102, 107)', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}, {'value': '42.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Minimally Improved (n=105, 102, 107)', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}, {'value': '38.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, No Change (n=105, 102, 107)', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}, {'value': '11.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Minimally Worse (n=105, 102, 107)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Much Worse (n=105, 102, 107)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Very Much Worse (n=105, 102, 107)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Very Much Improved (n=101, 101, 100)', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '13.9', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Much Improved (n=101, 101, 100)', 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000'}, {'value': '47.5', 'groupId': 'OG001'}, {'value': '44.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Minimally Improved (n=101, 101, 100)', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '27.7', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, No Change (n=101, 101, 100)', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '9.9', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Minimally Worse (n=101, 101, 100)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Much Worse (n=101, 101, 100)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Very Much Worse (n=101, 101, 100)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Very Much Improved (n=100, 100, 102)', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '26.0', 'groupId': 'OG001'}, {'value': '23.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Much Improved (n=100, 100, 102)', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}, {'value': '45.0', 'groupId': 'OG001'}, {'value': '45.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Minimally Improved (n=100, 100, 102)', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}, {'value': '20.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, No Change (n=100, 100, 102)', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Minimally Worse (n=100, 100, 102)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Much Worse (n=100, 100, 102)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Very Much Worse (n=100, 100, 102)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Very Much Improved (n=99, 101, 99)', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}, {'value': '30.7', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Much Improved (n=99, 101, 99)', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000'}, {'value': '47.5', 'groupId': 'OG001'}, {'value': '45.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Minimally Improved (n=99, 101, 99)', 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}, {'value': '16.8', 'groupId': 'OG001'}, {'value': '21.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, No Change (n=99, 101, 99)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Minimally Worse (n=99, 101, 99)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Much Worse (n=99, 101, 99)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Very Much Worse (n=99, 101, 99)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.924', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'Fluoxetine versus Placebo - Week 1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.698', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'DVS SR versus Placebo - Week 1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.214', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'Fluoxetine versus Placebo - Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.113', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'DVS SR versus Placebo - Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.314', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'Fluoxetine versus Placebo - Week 3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.659', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'DVS SR versus Placebo - Week 3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.577', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'Fluoxetine versus Placebo - Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.187', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'DVS SR versus Placebo - Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'Fluoxetine versus Placebo - Week 6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.266', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'DVS SR versus Placebo - Week 6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.095', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'Fluoxetine versus Placebo - Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.852', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".', 'groupDescription': 'DVS SR versus Placebo - Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 6, and 8', 'description': 'A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).'}, {'id': 'OG001', 'title': 'Fluoxetine', 'description': 'Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).'}, {'id': 'OG002', 'title': 'DVS SR', 'description': 'DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.'}], 'classes': [{'title': 'Week 1 (n=102, 101, 111)', 'categories': [{'measurements': [{'value': '8.82', 'groupId': 'OG000'}, {'value': '14.85', 'groupId': 'OG001'}, {'value': '9.01', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n=103, 105, 110)', 'categories': [{'measurements': [{'value': '29.13', 'groupId': 'OG000'}, {'value': '33.33', 'groupId': 'OG001'}, {'value': '35.45', 'groupId': 'OG002'}]}]}, {'title': 'Week 3 (n=105, 102, 107)', 'categories': [{'measurements': [{'value': '42.86', 'groupId': 'OG000'}, {'value': '50.98', 'groupId': 'OG001'}, {'value': '49.53', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=101, 101, 100)', 'categories': [{'measurements': [{'value': '54.46', 'groupId': 'OG000'}, {'value': '61.39', 'groupId': 'OG001'}, {'value': '64.00', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 (n=100, 100, 102)', 'categories': [{'measurements': [{'value': '59.00', 'groupId': 'OG000'}, {'value': '71.00', 'groupId': 'OG001'}, {'value': '68.63', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=99, 101, 99)', 'categories': [{'measurements': [{'value': '62.63', 'groupId': 'OG000'}, {'value': '78.22', 'groupId': 'OG001'}, {'value': '68.69', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.550', 'ciLowerLimit': '0.226', 'ciUpperLimit': '1.335', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'Fluoxetine versus Placebo - Week 1', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.984', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.990', 'ciLowerLimit': '0.382', 'ciUpperLimit': '2.567', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'DVS SR versus Placebo - Week 1', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.462', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.795', 'ciLowerLimit': '0.431', 'ciUpperLimit': '1.465', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'Fluoxetine versus Placebo - Week 2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.297', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.726', 'ciLowerLimit': '0.399', 'ciUpperLimit': '1.324', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'DVS SR versus Placebo - Week 2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.194', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.688', 'ciLowerLimit': '0.391', 'ciUpperLimit': '1.210', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'Fluoxetine versus Placebo - Week 3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.272', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.732', 'ciLowerLimit': '0.419', 'ciUpperLimit': '1.277', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'DVS SR versus Placebo - Week 3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.313', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.748', 'ciLowerLimit': '0.426', 'ciUpperLimit': '1.314', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'Flouxetine versus Placebo - Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.157', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.663', 'ciLowerLimit': '0.376', 'ciUpperLimit': '1.171', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'DVS SR versus Placebo - Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.579', 'ciLowerLimit': '0.319', 'ciUpperLimit': '1.050', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'Flouxetine versus Placebo - Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.135', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.640', 'ciLowerLimit': '0.356', 'ciUpperLimit': '1.149', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'DVS SR versus Placebo - Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.465', 'ciLowerLimit': '0.249', 'ciUpperLimit': '0.871', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'Flouxetine versus Placebo - Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.343', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.751', 'ciLowerLimit': '0.415', 'ciUpperLimit': '1.357', 'estimateComment': 'Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.', 'groupDescription': 'DVS SR versus Placebo - Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 2, 3, 4, 6, and 8', 'description': 'A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).'}, {'id': 'FG001', 'title': 'Fluoxetine', 'description': 'Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase).'}, {'id': 'FG002', 'title': 'Desvenlafaxine Succinate Sustained Release (DVS SR)', 'description': 'DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '115'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '112'}, {'groupId': 'FG002', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '339', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).'}, {'id': 'BG001', 'title': 'Fluoxetine', 'description': 'Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).'}, {'id': 'BG002', 'title': 'DVS SR', 'description': 'DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '2.89', 'groupId': 'BG000'}, {'value': '12.6', 'spread': '2.89', 'groupId': 'BG001'}, {'value': '12.9', 'spread': '3.12', 'groupId': 'BG002'}, {'value': '12.7', 'spread': '2.96', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population - included all randomized participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-02', 'studyFirstSubmitDate': '2011-06-09', 'resultsFirstSubmitDate': '2015-10-19', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-19', 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score", 'timeFrame': 'Baseline and Week 8', 'description': "Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score', 'timeFrame': 'Baseline and Week 8', 'description': "A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented."}, {'measure': 'Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 6, and 8', 'description': 'A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.'}, {'measure': "Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'", 'timeFrame': 'Weeks 1, 2, 3, 4, 6, and 8', 'description': 'A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. 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