Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT01377194
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2011-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078862', 'term': 'Levomilnacipran'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carl.gommoll@frx.com', 'phone': '201-427-8000', 'title': 'Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry', 'phoneExt': '8124', 'organization': 'Forest Research Institute'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.\n\nPublication of the results by the PI will be patient to mutual agreement between the PI and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over a 10 month period from June 2011 to March 2012.', 'description': 'The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.', 'otherNumAtRisk': 186, 'otherNumAffected': 58, 'seriousNumAtRisk': 186, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Levomilnacipran ER 40 mg', 'description': '40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.', 'otherNumAtRisk': 188, 'otherNumAffected': 90, 'seriousNumAtRisk': 188, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Levomilnacipran 80 mg', 'description': '40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.', 'otherNumAtRisk': 188, 'otherNumAffected': 110, 'seriousNumAtRisk': 188, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary hesitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Facial Bones Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose matched placebo oral administration in capsule form, once daily, for 8 weeks.'}, {'id': 'OG001', 'title': 'Levomilnacipran ER 40 mg', 'description': '40mg Levomilnacipran ER oral administration in capsule form, once daily, for 8 weeks.'}, {'id': 'OG002', 'title': 'Levomilnacipran ER 80 mg', 'description': '80mg of Levomilnacipran ER oral administration in capsule form, once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.3', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-14.6', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '-14.4', 'spread': '0.79', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.303', 'ciLowerLimit': '-5.457', 'ciUpperLimit': '-1.148', 'statisticalMethod': 'mixed-model for repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0043', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.141', 'ciLowerLimit': '-5.293', 'ciUpperLimit': '-0.988', 'statisticalMethod': 'mixed-model for repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 8', 'description': 'The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.'}, {'type': 'SECONDARY', 'title': 'Change in Sheehan Disability Scale (SDS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Levomilnacipran ER 40 mg', 'description': '40mg Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks'}, {'id': 'OG002', 'title': 'Levomilnacipran ER 80 mg', 'description': '80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.4', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '-8.2', 'spread': '0.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0459', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.827', 'ciLowerLimit': '-3.620', 'ciUpperLimit': '-0.033', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed-effects model for repeated measures.', 'testedNonInferiority': False}, {'pValue': '0.0028', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.720', 'ciLowerLimit': '-4.494', 'ciUpperLimit': '-0.946', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Mixed-effects model for repeated measures.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 8', 'description': 'The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.'}, {'id': 'FG001', 'title': 'Levomilnacipran ER 40 mg', 'description': '40mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks'}, {'id': 'FG002', 'title': 'Levomilnacipran ER 80 mg', 'description': '80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '188'}, {'groupId': 'FG002', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Patient recruitment occurred during a 6 month period from June to December 2011 at 47 study sites in the United States and 4 study sites in Canada.', 'preAssignmentDetails': 'All patients went through a 1-week single-blind placebo run-in period before randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '562', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.'}, {'id': 'BG001', 'title': 'Levomilnacipran ER 40 mg', 'description': '40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.'}, {'id': 'BG002', 'title': 'Levomilnacipran 80 mg', 'description': '40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '42.9', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '43.1', 'spread': '12.8', 'groupId': 'BG002'}, {'value': '42.8', 'spread': '13.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 20', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': '≥ 20-29', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}, {'title': '≥ 30-39', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}]}, {'title': '≥ 40-49', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}]}, {'title': '≥ 50-59', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}, {'title': '≥ 60', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '357', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '416', 'groupId': 'BG003'}]}]}, {'title': 'Black or African-American', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'American Indian of Alaska Native', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Other Race', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}, {'title': 'Non-Hispanic', 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}, {'value': '500', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.60', 'spread': '17.77', 'groupId': 'BG000'}, {'value': '81.35', 'spread': '17.09', 'groupId': 'BG001'}, {'value': '81.73', 'spread': '17.57', 'groupId': 'BG002'}, {'value': '81.56', 'spread': '17.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.41', 'spread': '9.69', 'groupId': 'BG000'}, {'value': '169.48', 'spread': '9.79', 'groupId': 'BG001'}, {'value': '168.63', 'spread': '8.91', 'groupId': 'BG002'}, {'value': '168.84', 'spread': '9.47', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.67', 'spread': '5.19', 'groupId': 'BG000'}, {'value': '28.25', 'spread': '5.17', 'groupId': 'BG001'}, {'value': '28.71', 'spread': '5.68', 'groupId': 'BG002'}, {'value': '28.54', 'spread': '5.35', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms Per Meter Squared', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Baseline Participant population is based on the 562 randomized patients who went on to receive double-blind treatment (Safety Population).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 568}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'dispFirstSubmitDate': '2012-04-27', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-22', 'studyFirstSubmitDate': '2011-06-10', 'dispFirstSubmitQcDate': '2012-04-27', 'resultsFirstSubmitDate': '2013-08-22', 'studyFirstSubmitQcDate': '2011-06-17', 'dispFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-22', 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.', 'timeFrame': 'From Baseline to Week 8', 'description': 'The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).'}], 'secondaryOutcomes': [{'measure': 'Change in Sheehan Disability Scale (SDS) Total Score', 'timeFrame': 'From Baseline to Week 8', 'description': 'The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Major Depressive Disorder'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '26644957', 'type': 'DERIVED', 'citation': 'Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.'}, {'pmid': '24144196', 'type': 'DERIVED', 'citation': 'Bakish D, Bose A, Gommoll C, Chen C, Nunez R, Greenberg WM, Liebowitz M, Khan A. Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci. 2014 Jan;39(1):40-9. doi: 10.1503/jpn.130040.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women, 18-75 years old\n* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder\n* The patient's current depressive episode must be at least 6 weeks in duration\n\nExclusion Criteria:\n\n* Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.\n* Patients who are considered a suicide risk\n* Patients with a history of meeting DSM-IV-TR criteria for\n* a. any manic or hypomanic episode\n* b. schizophrenia or any other psychotic disorder\n* c. obsessive-compulsive disorder."}, 'identificationModule': {'nctId': 'NCT01377194', 'briefTitle': 'Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'LVM-MD-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '40mg Levomilnacipran ER', 'interventionNames': ['Drug: Levomilnacipran ER']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '80mg of Levomilnacipran ER', 'interventionNames': ['Drug: Levomilnacipran ER']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Levomilnacipran ER', 'type': 'DRUG', 'description': 'Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks', 'armGroupLabels': ['1']}, {'name': 'Levomilnacipran ER', 'type': 'DRUG', 'description': 'Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 039', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 037', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 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