Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-29 @ 7:25 AM
Study NCT ID:
NCT01371734
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2011-06-09
Is 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', 'removedCountries': ['Puerto Rico']}, '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'}]}}, '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 8 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': 'Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.', 'otherNumAtRisk': 120, 'otherNumAffected': 34, 'seriousNumAtRisk': 120, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'DVS SR Low Dose', 'description': 'DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.', 'otherNumAtRisk': 122, 'otherNumAffected': 46, 'seriousNumAtRisk': 122, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'DVS SR High Dose', 'description': 'DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.', 'otherNumAtRisk': 121, 'otherNumAffected': 53, 'seriousNumAtRisk': 121, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dermatomyositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], '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 (n=102, 104, 106)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'OG001', 'title': 'DVS SR Low Dose', 'description': 'DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'OG002', 'title': 'DVS SR High Dose', 'description': 'DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.85', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-23.70', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '-24.37', 'spread': '1.12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.587', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '-2.23', 'ciUpperLimit': '3.94', 'groupDescription': 'Adjusted mean difference = Placebo - DVS SR Low Dose', 'statisticalMethod': 'Mixed-effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hochberg procedure was used to control for multiplicity'}, {'pValue': '0.333', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '-1.56', 'ciUpperLimit': '4.61', 'groupDescription': 'Adjusted mean difference = Placebo - DVS SR High Dose', 'statisticalMethod': 'Mixed-effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hochberg procedure was used to control for multiplicity'}], 'paramType': 'LEAST_SQUARES_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. Mean change from baseline was adjusted for the baseline total score, age group and gender.", '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.\n\nn is the number of participants with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'OG001', 'title': 'DVS SR Low Dose', 'description': 'DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'OG002', 'title': 'DVS SR High Dose', 'description': 'DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.49', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '-1.65', 'spread': '0.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.923', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.015', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.32', 'groupDescription': 'Adjusted mean difference = Placebo - DVS SR Low Dose', 'statisticalMethod': 'Mixed-effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hochberg procedure was used to control for multiplicity'}, {'pValue': '0.302', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.161', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.47', 'groupDescription': 'Adjusted mean difference = Placebo - DVS SR High Dose', 'statisticalMethod': 'Mixed-effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Hochberg procedure was used to control for multiplicity'}], 'paramType': 'LEAST_SQUARES_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. Mean change from baseline was adjusted for the baseline total score, age group and gender.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population n is the number of participants with evaluable data.'}, {'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': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'OG001', 'title': 'DVS SR Low Dose', 'description': 'DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'OG002', 'title': 'DVS SR High Dose', 'description': 'DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}], 'classes': [{'title': 'Week 1, Very Much Improved (n=113, 112,115)', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, Much Improved (n=113, 112, 115)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '9.8', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, Minimally Improved (n=113, 112, 115)', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}, {'value': '33.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, No Change (n=113, 112, 115)', 'categories': [{'measurements': [{'value': '49.6', 'groupId': 'OG000'}, {'value': '51.8', 'groupId': 'OG001'}, {'value': '46.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, Minimally Worse (n=113, 112, 115)', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, Much Worse (n=113, 112, 115)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 1, Very Much Worse (n=113, 112, 115)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Very Much Improved (n=114, 115, 109)', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Much Improved (n=114, 115, 109)', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '26.1', 'groupId': 'OG001'}, {'value': '23.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Minimally Improved (n=114, 115, 109)', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}, {'value': '38.3', 'groupId': 'OG001'}, {'value': '35.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, No Change (n=114, 115, 109)', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '25.2', 'groupId': 'OG001'}, {'value': '29.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Minimally Worse (n=114, 115, 109)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Much Worse (n=114, 115, 109)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 2, Very Much Worse (n=114, 115, 109)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Very Much Improved (n=108, 110, 110)', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}, {'value': '18.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Much Improved (n=108, 110, 110)', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '26.4', 'groupId': 'OG001'}, {'value': '24.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Minimally Improved (n=108, 110, 110)', 'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000'}, {'value': '44.5', 'groupId': 'OG001'}, {'value': '35.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, No Change (n=108, 110, 110)', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '15.5', 'groupId': 'OG001'}, {'value': '21.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Minimally Worse (n=108, 110, 110)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Much Worse (n=108, 110, 110)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 3, Very Much Worse (n=108, 110, 110)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Very Much Improved (n=104,108,113)', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Much Improved (n=104,108,113)', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}, {'value': '31.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Minimally Improved (n=104,108,113)', 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000'}, {'value': '30.6', 'groupId': 'OG001'}, {'value': '35.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, No Change (n=104,108,113)', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '14.8', 'groupId': 'OG001'}, {'value': '17.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Minimally Worse (n=104,108,113)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Much Worse (n=104,108,113)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4, Very Much Worse (n=104,108,113)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Very Much Improved (n=106,104,104)', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '20.2', 'groupId': 'OG001'}, {'value': '26.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Much Improved (n=106,104,104)', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '36.5', 'groupId': 'OG001'}, {'value': '24.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Minimally Improved (n=106,104,104)', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}, {'value': '31.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, No Change (n=106,104,104)', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '14.4', 'groupId': 'OG001'}, {'value': '14.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Minimally Worse (n=106,104,104)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Much Worse (n=106,104,104)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 6, Very Much Worse (n=106,104,104)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Very Much Improved (n=102,105,106)', 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000'}, {'value': '19.0', 'groupId': 'OG001'}, {'value': '25.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Much Improved (n=102,105,106)', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '37.1', 'groupId': 'OG001'}, {'value': '36.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Minimally Improved (n=102,105,106)', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '24.8', 'groupId': 'OG001'}, {'value': '21.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, No Change (n=102,105,106)', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000'}, {'value': '18.1', 'groupId': 'OG001'}, {'value': '15.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Minimally Worse (n=102,105,106)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Much Worse (n=102,105,106)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Very Much Worse (n=102,105,106)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.729', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.756', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.765', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.475', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.310', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.105', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 3', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.254', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.887', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.475', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.407', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.696', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.462', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', '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 equals (=) more affected.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population n is the number of participants with non-missing values'}, {'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': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'OG001', 'title': 'DVS SR Low Dose', 'description': 'DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'OG002', 'title': 'DVS SR High Dose', 'description': 'DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}], 'classes': [{'title': 'Week 1 (n=113, 112, 115)', 'categories': [{'measurements': [{'value': '8.85', 'groupId': 'OG000'}, {'value': '10.71', 'groupId': 'OG001'}, {'value': '14.78', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n=114, 115, 109)', 'categories': [{'measurements': [{'value': '30.70', 'groupId': 'OG000'}, {'value': '32.17', 'groupId': 'OG001'}, {'value': '33.94', 'groupId': 'OG002'}]}]}, {'title': 'Week 3 (n=108, 110, 110)', 'categories': [{'measurements': [{'value': '30.56', 'groupId': 'OG000'}, {'value': '37.27', 'groupId': 'OG001'}, {'value': '42.73', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=104, 108, 113)', 'categories': [{'measurements': [{'value': '45.19', 'groupId': 'OG000'}, {'value': '53.70', 'groupId': 'OG001'}, {'value': '46.02', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 (n=106, 104, 104)', 'categories': [{'measurements': [{'value': '49.06', 'groupId': 'OG000'}, {'value': '56.73', 'groupId': 'OG001'}, {'value': '50.96', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=102, 105, 106)', 'categories': [{'measurements': [{'value': '55.88', 'groupId': 'OG000'}, {'value': '56.19', 'groupId': 'OG001'}, {'value': '62.26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.806', 'ciLowerLimit': '0.333', 'ciUpperLimit': '1.951', 'groupDescription': 'Week 1', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.172', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.561', 'ciLowerLimit': '0.245', 'ciUpperLimit': '1.285', 'groupDescription': 'Week 1', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.826', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.939', 'ciLowerLimit': '0.536', 'ciUpperLimit': '1.644', 'groupDescription': 'Week 2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.599', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.860', 'ciLowerLimit': '0.489', 'ciUpperLimit': '1.511', 'groupDescription': 'Week 2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.713', 'ciLowerLimit': '0.402', 'ciUpperLimit': '1.265', 'groupDescription': 'Week 3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.048', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.564', 'ciLowerLimit': '0.320', 'ciUpperLimit': '0.995', 'groupDescription': 'Week 3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.210', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.708', 'ciLowerLimit': '0.412', 'ciUpperLimit': '1.216', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.893', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.964', 'ciLowerLimit': '0.564', 'ciUpperLimit': '1.646', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.228', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.714', 'ciLowerLimit': '0.413', 'ciUpperLimit': '1.235', 'groupDescription': 'Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.751', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.916', 'ciLowerLimit': '0.531', 'ciUpperLimit': '1.579', 'groupDescription': 'Week 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.925', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.974', 'ciLowerLimit': '0.561', 'ciUpperLimit': '1.689', 'groupDescription': 'Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.342', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.764', 'ciLowerLimit': '0.438', 'ciUpperLimit': '1.331', 'groupDescription': '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) or 2 (much improved) on the scale. Higher score = more affected.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population n is the number of participants with non-missing values'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'FG001', 'title': 'DVS SR Low Dose', 'description': 'DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'FG002', 'title': 'DVS SR High Dose', 'description': 'DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '363', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'BG001', 'title': 'DVS SR Low Dose', 'description': 'DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'BG002', 'title': 'DVS SR High Dose', 'description': 'DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'spread': '2.68', 'groupId': 'BG000'}, {'value': '13.1', 'spread': '2.80', 'groupId': 'BG001'}, {'value': '12.9', 'spread': '3.01', 'groupId': 'BG002'}, {'value': '13.0', 'spread': '2.83', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '158', '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': 363}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2011-06-09', 'resultsFirstSubmitDate': '2016-03-07', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-30', 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)", '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. Mean change from baseline was adjusted for the baseline total score, age group and gender."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)', '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. Mean change from baseline was adjusted for the baseline total score, age group and gender."}, {'measure': 'Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8', '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 equals (=) 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) or 2 (much improved) on the scale. Higher score = more affected.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'MDD', 'Depression'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '29185786', 'type': 'DERIVED', 'citation': 'Atkinson S, Lubaczewski S, Ramaker S, England RD, Wajsbrot DB, Abbas R, Findling RL. Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):55-65. doi: 10.1089/cap.2017.0099. Epub 2017 Nov 29.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2061032&StudyName=A%20Study%20Of%20DVS%20SR%20In%20Treatment%20Of%20Children%20And%20Adolescent%20Outpatients%20With%20MDD', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=7 and \\<18 years of age\n* Primary diagnosis of major depressive disorder (MDD)\n* CDRS-R score \\>40\n\nExclusion Criteria:\n\n* History of suicidal behavior or requires precaution against suicide\n* Not in generally healthy medical condition\n* History of psychosis or bipolar disorder\n* Seizure disorder'}, 'identificationModule': {'nctId': 'NCT01371734', 'briefTitle': 'A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy, Safety And Tolerability Of Desvenlafaxine Succinate Sustained-release (Dvs Sr) In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'B2061032'}, 'secondaryIdInfos': [{'id': '3151A6-3343', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2008-001875-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 1 - high dose', 'interventionNames': ['Drug: Desvenlafaxine Succinate Sustained-Release']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 2 - low dose', 'interventionNames': ['Drug: Desvenlafaxine Succinate Sustained-Release']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Desvenlafaxine Succinate Sustained-Release', 'type': 'DRUG', 'description': 'Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.', 'armGroupLabels': ['Experimental Arm 1 - high dose']}, {'name': 'Desvenlafaxine Succinate Sustained-Release', 'type': 'DRUG', 'description': 'Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.', 'armGroupLabels': ['Experimental Arm 2 - low dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects randomized to the Placebo treatment arm will receive placebo tablets', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 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