Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-03 @ 7:59 PM
Study NCT ID:
NCT01085812
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2010-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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. Publication 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}, 'limitationsAndCaveats': {'description': 'This was a failed study. The lower than expected rate of relapse in the placebo group compromised the projected power to demonstrate a difference between groups.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collection over a 20-month period from March 2010 to November 2011 at 36 study sites in the U.S and Canada.', '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 24 week double-blind treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Open Label Levomilnacipran ER', 'description': '40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing.', 'otherNumAtRisk': 734, 'deathsNumAtRisk': 734, 'otherNumAffected': 448, 'seriousNumAtRisk': 734, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Placebo - Double Blind Treatment', 'description': 'Matching placebo capsules, oral administration, once daily dosing.', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 31, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Levomilnacipran ER - Double Blind Treatment', 'description': '40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing.', 'otherNumAtRisk': 233, 'deathsNumAtRisk': 233, 'otherNumAffected': 68, 'seriousNumAtRisk': 233, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood creatine phosphokinase MB increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suicidal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 734, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Relapse (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo capsules, oral administration, once daily dosing.'}, {'id': 'OG001', 'title': 'Levomilnacipran ER', 'description': '40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Relapse did not occur within the 24-week time frame of the study', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Relapse did not occur within the 24-week time frame of the study', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': 'Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The double blind Intent-to-treat population consists of 342 randomized participants who received study drug and were evaluated for the Primary Outcome Measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matching placebo capsules, oral administration, once daily dosing.'}, {'id': 'FG001', 'title': 'Levomilnacipran ER', 'description': '40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.'}], 'periods': [{'title': 'Open-Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '734'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '494'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '240'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '42'}]}]}, {'title': 'Double-Blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Double-blind Intent-to-treat Population', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Positive serum pregnancy test result', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patient were recruited over a 10-month period from March of 2010 to January of 2011 at 36 studies sites, 30 in the United States and 6 in Canada.', 'preAssignmentDetails': 'Patients began with a 12-week open-label treatment period, followed by a 24-week double-blind treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Label Levomilnacipran ER', 'description': '40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '12.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 years to 19 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': '20 years to 29 years', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}]}]}, {'title': '30 years to 39 years', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}, {'title': '40 years to 49 years', 'categories': [{'measurements': [{'value': '208', 'groupId': 'BG000'}]}]}, {'title': '50 years to 59 years', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}]}]}, {'title': '60 years to 65 years', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '425', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '309', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '683', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '83.41', 'spread': '18.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.88', 'spread': '5.42', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms Per Meter Squared', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Baseline Participant population is based on the 734 enrolled patients who received at least one dose of open-label treatment.'}}, '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': 734}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2011-12-29', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-23', 'studyFirstSubmitDate': '2010-03-10', 'dispFirstSubmitQcDate': '2011-12-29', 'resultsFirstSubmitDate': '2013-08-22', 'studyFirstSubmitQcDate': '2010-03-11', 'dispFirstPostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-23', 'studyFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Relapse (Days)', 'timeFrame': '24 Weeks', 'description': 'Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).', 'detailedDescription': 'Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women, 18-65 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': 'NCT01085812', 'briefTitle': 'Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'LVM-MD-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': '40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.', 'interventionNames': ['Drug: Levomilnacipran ER']}, {'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Matching placebo capsules, oral administration, once daily dosing.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Levomilnacipran ER', 'type': 'DRUG', 'description': 'Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to be given orally, in capsule form, once daily.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site #023', 'geoPoint': {'lat': 34.07362, 'lon': 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{'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Forest Investigative Site #018', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Forest Investigative Site #027', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'V1Y 1Z9', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Forest Investigative Site #050', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V6Z 2L4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Forest Investigative Site #051', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B1S 2E8', 'city': 'Sydney', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Forest Investigative Site #052', 'geoPoint': {'lat': 46.1351, 'lon': -60.1831}}, {'zip': 'N7M 1B7', 'city': 'Chatham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Forest Investigative Site #055', 'geoPoint': {'lat': 42.41224, 'lon': -82.18494}}, {'zip': 'K1G 4G3', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Forest Investigative Site #053', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Giovanna Forero, MA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Forest Laboratories'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}