Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-01-22 @ 8:19 AM
Study NCT ID:
NCT02431806
Status:
COMPLETED
Last Update Posted:
2020-09-07
First Post:
2015-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078862', 'term': 'Levomilnacipran'}, {'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D000078764', 'term': 'Milnacipran'}, {'id': 'D003521', 'term': 'Cyclopropanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study treatment to end of study follow-up (Up to 10 Weeks)', 'description': 'Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.', 'otherNumAtRisk': 141, 'deathsNumAtRisk': 141, 'otherNumAffected': 33, 'seriousNumAtRisk': 141, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Levomilnacipran 40 mg/Day', 'description': 'Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 54, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Levomilnacipran 80 mg/Day', 'description': 'Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.', 'otherNumAtRisk': 138, 'deathsNumAtRisk': 138, 'otherNumAffected': 63, 'seriousNumAtRisk': 138, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Fluoxetine 20 mg/Day', 'description': 'Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 41, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}], 'seriousEvents': [{'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA : 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.'}, {'id': 'OG001', 'title': 'Levomilnacipran 40 mg/Day', 'description': 'Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.'}, {'id': 'OG002', 'title': 'Levomilnacipran 80 mg/Day', 'description': 'Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.'}, {'id': 'OG003', 'title': 'Fluoxetine 20 mg/Day', 'description': 'Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.90', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-23.28', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '-22.64', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '-24.37', 'spread': '1.12', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-3.41', 'ciUpperLimit': '2.64', 'estimateComment': 'Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Model Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8681', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-2.80', 'ciUpperLimit': '3.31', 'estimateComment': 'Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3439', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.47', 'ciLowerLimit': '-4.52', 'ciUpperLimit': '1.58', 'estimateComment': 'Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0) to Week 8', 'description': 'CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.'}, {'id': 'OG001', 'title': 'Levomilnacipran 40 mg/Day', 'description': 'Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.'}, {'id': 'OG002', 'title': 'Levomilnacipran 80 mg/Day', 'description': 'Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.'}, {'id': 'OG003', 'title': 'Fluoxetine 20 mg/Day', 'description': 'Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.54', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-1.52', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '-1.68', 'spread': '0.10', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8788', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.29', 'estimateComment': 'Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9230', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.29', 'estimateComment': 'Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2895', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.13', 'estimateComment': 'Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0) to Week 8', 'description': 'The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score. Overall number of participants analyzed is the number of participants with data available for analyses."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.'}, {'id': 'FG001', 'title': 'Levomilnacipran 40 mg/Day', 'description': 'Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.'}, {'id': 'FG002', 'title': 'Levomilnacipran 80 mg/Day', 'description': 'Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.'}, {'id': 'FG003', 'title': 'Fluoxetine 20 mg/Day', 'description': 'Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.'}], 'periods': [{'title': 'Double-blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '136'}, {'groupId': 'FG002', 'numSubjects': '139'}, {'groupId': 'FG003', 'numSubjects': '135'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '138'}, {'groupId': 'FG003', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Did not Receive Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Investigational Product Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}, {'title': 'Double-blind Down-taper Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '547', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.'}, {'id': 'BG001', 'title': 'Levomilnacipran 40 mg/Day', 'description': 'Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.'}, {'id': 'BG002', 'title': 'Levomilnacipran 80 mg/Day', 'description': 'Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.'}, {'id': 'BG003', 'title': 'Fluoxetine 20 mg/Day', 'description': 'Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '547', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '1.59', 'groupId': 'BG000'}, {'value': '14.8', 'spread': '1.62', 'groupId': 'BG001'}, {'value': '14.8', 'spread': '1.75', 'groupId': 'BG002'}, {'value': '14.7', 'spread': '1.67', 'groupId': 'BG003'}, {'value': '14.7', 'spread': '1.67', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '547', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '363', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '184', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '547', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '410', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '547', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '187', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '333', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Children's Depression Rating Scale-Revised (CDRS-R) Total Score", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '546', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '61.1', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '83'}, {'value': '61.8', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '88'}, {'value': '59.4', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '81'}, {'value': '61.5', 'groupId': 'BG003', 'lowerLimit': '40', 'upperLimit': '92'}, {'value': '60.95', 'groupId': 'BG004', 'lowerLimit': '32', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'description': 'CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Intent to Treat (ITT) Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score.'}, {'title': 'Clinical Global Impression-Severity (CGI-S) Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '546', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '4.8', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '4.7', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '4.7', 'groupId': 'BG003', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '4.7', 'groupId': 'BG004', 'lowerLimit': '3', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'description': "The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with major depressive disorder (MDD) population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.'}], 'populationDescription': 'Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-03', 'size': 1519858, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-08-19T20:15', 'hasProtocol': False}, {'date': '2019-03-25', 'size': 1455786, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-19T20:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-19', 'studyFirstSubmitDate': '2015-04-28', 'resultsFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2015-04-30', 'lastUpdatePostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-19', 'studyFirstPostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score", 'timeFrame': 'Baseline (Week 0) to Week 8', 'description': 'CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale', 'timeFrame': 'Baseline (Week 0) to Week 8', 'description': 'The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '38700708', 'type': 'DERIVED', 'citation': 'Radecki DT, Robieson WZ, Gopalkrishnan M, Greenberg E, Aziz M. Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies. J Child Adolesc Psychopharmacol. 2024 Jun;34(5):241-250. doi: 10.1089/cap.2023.0080. Epub 2024 May 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for future pediatric studies of levomilnacipran.', 'detailedDescription': 'Study LVM-MD-11 is a randomized, double-blind, placebo- and active-controlled, parallel group, fixed-dose study in adolescent patients, ages 12-17 years. The study will be approximately 10 weeks in duration:\n\n* 1-week screening/washout period\n* 8-week double-blind treatment period\n* 1-week double-blind down-taper period\n\nParticipants who meet the eligibility criteria at Visit 2 (Baseline) will be randomized to 1 of 4 treatment groups: placebo, levomilnacipran 40 mg/day, levomilnacipran 80 mg/day, or fluoxetine 20 mg/day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Male or female outpatients;12-17 years of age\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)\n* Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2\n* Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2\n* Reliable caregiver\n* Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant\n\nKey Psychiatric Exclusion Criteria:\n\n* DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment\n* Mental retardation or amnestic or other cognitive disorders\n* Significant suicide risk:\n* Suicide attempt within the past year OR\n* Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))\n\nKey Treatment-Related Exclusion Criteria:\n\n* Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)\n* Use of prohibited concomitant medication that cannot be discontinued\n\nOther Key Medical Exclusion Criteria:\n\n* Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety\n* Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \\> 2X the upper limit of normal (ULN)\n* Clinically significant cardiovascular disorders\n* Seizure disorder or risk of seizure\n* Drug or alcohol abuse or dependence (within the past year)\n* Positive urine drug screen or blood alcohol"}, 'identificationModule': {'nctId': 'NCT02431806', 'briefTitle': 'Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder', 'nctIdAliases': ['NCT03087916'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'LVM-MD-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Levomilnacipran 40 mg', 'description': 'Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.', 'interventionNames': ['Drug: Levomilnacipran']}, {'type': 'EXPERIMENTAL', 'label': 'Levomilnacipran 80 mg', 'description': 'Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.', 'interventionNames': ['Drug: Levomilnacipran']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoxetine 20 mg', 'description': 'Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.', 'interventionNames': ['Drug: Fluoxetine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.', 'armGroupLabels': ['Placebo']}, {'name': 'Levomilnacipran', 'type': 'DRUG', 'otherNames': ['Fetzima'], 'description': 'Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.', 'armGroupLabels': ['Levomilnacipran 40 mg', 'Levomilnacipran 80 mg']}, {'name': 'Fluoxetine', 'type': 'DRUG', 'otherNames': ['Prozac'], 'description': 'Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.', 'armGroupLabels': ['Fluoxetine 20 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36303', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Harmonex, Inc', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Department of Psychiatry', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Research Center, Inc.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'ProScience Research Group', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '92251', 'city': 'Imperial', 'state': 'California', 'country': 'United States', 'facility': 'Sun Valley Research Center', 'geoPoint': {'lat': 32.84755, 'lon': -115.56944}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Alliance for Research', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'Asclepes Research Centers', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '97025', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Syrentis Clinical Research', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Clinical Research Medical Group', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'MCB Clinical Research Center', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center; 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