Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-29 @ 8:57 AM
Study NCT ID:
NCT00969150
Status:
COMPLETED
Last Update Posted:
2013-10-25
First Post:
2009-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Levomilnacipran ER (F2695 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 Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.', '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': 'Matching placebo capsules, oral administration, once daily dosing for 8 weeks.', 'otherNumAtRisk': 182, 'otherNumAffected': 58, 'seriousNumAtRisk': 182, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Levomilnacipran ER', 'description': 'Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.', 'otherNumAtRisk': 175, 'otherNumAffected': 90, 'seriousNumAtRisk': 175, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ejaculation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo capsules, oral administration, once daily dosing for 8 weeks.'}, {'id': 'OG001', 'title': 'Levomilnacipran ER', 'description': 'Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.2', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-15.7', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2492', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.49', 'ciLowerLimit': '-4.02', 'ciUpperLimit': '1.05', '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': 'MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.\n\nEach item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 357 patients who received at least 1 dose of double-blind treatment (Safety Population), 355 patients had at least 1 postbaseline MADRS assessment (Intent to Treat \\[ITT\\] Population).'}, {'type': 'SECONDARY', 'title': 'Change in Sheehan Disability Scale (SDS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo capsules, oral administration, once daily dosing for 8 weeks.'}, {'id': 'OG001', 'title': 'Levomilnacipran ER', 'description': 'Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.2', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5625', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-2.38', 'ciUpperLimit': '1.29', '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'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Dose Matched placebo capsules, oral administration, once daily dosing for 8 weeks.'}, {'id': 'FG001', 'title': 'Levomilnacipran ER', 'description': 'Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patient were recruited over a 12-month period from September of 2009 to September of 2010 at 24 studies sites in the United States.', 'preAssignmentDetails': 'Patients went through a 1-week single-blind placebo run-in period immediately preceding an 8-week double-blind treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matching placebo capsules, oral administration, once daily dosing for 8 weeks.'}, {'id': 'BG001', 'title': 'Levomilnacipran ER', 'description': 'Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '42.8', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '43.3', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 years to 19 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': '20 years to 29 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': '30 years to 39 years', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': '40 years to 49 years', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': '50 years to 59 years', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': '60 years to 80 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '82.9', 'spread': '18.0', 'groupId': 'BG000'}, {'value': '82.4', 'spread': '18.1', 'groupId': 'BG001'}, {'value': '82.7', 'spread': '18.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '28.7', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '28.8', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms Per Meter Squared', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'While a total of 362 patients were randomized to receive double-blind treatment, 5 of these patients were either lost to follow up or withdrew consent before receiving double-blind treatment. The Baseline Participant population is based on the 357 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', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'dispFirstSubmitDate': '2012-03-01', 'lastUpdateSubmitDate': '2013-08-22', 'studyFirstSubmitDate': '2009-08-31', 'dispFirstSubmitQcDate': '2012-03-01', 'resultsFirstSubmitDate': '2013-08-22', 'studyFirstSubmitQcDate': '2009-08-31', 'dispFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-22', 'studyFirstPostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': 'From Baseline to Week 8', 'description': 'MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.\n\nEach item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 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': ['Major Depressive Disorder', 'Depression'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '27536449', 'type': 'DERIVED', 'citation': 'Gommoll CP, Greenberg WM, Chen C. A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40-120 mg/day) in patients with major depressive disorder. J Drug Assess. 2014 Jan 16;3(1):10-9. doi: 10.3109/21556660.2014.884505. eCollection 2014.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women, 18-80 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 4 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 with a history of meeting DSM-IV-TR criteria for:\n\n * any manic or hypomanic episode\n * schizophrenia or any other psychotic disorder\n * obsessive-compulsive disorder\n* Patients who are considered a suicide risk"}, 'identificationModule': {'nctId': 'NCT00969150', 'briefTitle': 'Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'LVM-MD-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Matching placebo capsules, oral administration, once daily dosing.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.', 'interventionNames': ['Drug: Levomilnacipran ER']}], 'interventions': [{'name': 'Levomilnacipran ER', 'type': 'DRUG', 'description': 'Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85254', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '92056', 'city': 'Oceanside', 'state': 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