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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."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"All patients went through a 1-week single-blind placebo run-in period before randomization.","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.","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 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The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).","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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"From Baseline to Week 8","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"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"185"},{"groupId":"OG002","value":"187"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.3","spread":"0.77"},{"groupId":"OG001","value":"-14.6","spread":"0.79"},{"groupId":"OG002","value":"-14.4","spread":"0.79"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0027","statisticalMethod":"mixed-model for repeated measures","paramType":"Least squares mean difference","paramValue":"-3.303","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.457","ciUpperLimit":"-1.148"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0043","statisticalMethod":"mixed-model for repeated measures","paramType":"Least squares mean difference","paramValue":"-3.141","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.293","ciUpperLimit":"-0.988"}]},{"type":"SECONDARY","title":"Change in Sheehan Disability Scale (SDS) Total Score","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. 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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.","seriousNumAffected":1,"seriousNumAtRisk":186,"otherNumAffected":58,"otherNumAtRisk":186},{"id":"EG001","title":"Levomilnacipran ER 40 mg","description":"40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.","seriousNumAffected":3,"seriousNumAtRisk":188,"otherNumAffected":90,"otherNumAtRisk":188},{"id":"EG002","title":"Levomilnacipran 80 mg","description":"40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.","seriousNumAffected":0,"seriousNumAtRisk":188,"otherNumAffected":110,"otherNumAtRisk":188}],"seriousEvents":[{"term":"Facial Bones Fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 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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."},"pointOfContact":{"title":"Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry","organization":"Forest Research Institute","email":"carl.gommoll@frx.com","phone":"201-427-8000","phoneExt":"8124"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"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"}]}},"hasResults":true}