{"protocolSection":{"identificationModule":{"nctId":"NCT04345471","orgStudyIdInfo":{"id":"MD120101"},"secondaryIdInfos":[{"id":"JapicCTI-205252","type":"REGISTRY","domain":"JapicCTI"}],"organization":{"fullName":"Mochida Pharmaceutical Company, Ltd.","class":"INDUSTRY"},"briefTitle":"A Study of MD-120 in Patients With Depression","officialTitle":"A Placebo-controlled Study of MD-120 in Patients With Depression"},"statusModule":{"statusVerifiedDate":"2024-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-05-18","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-07-21","type":"ACTUAL"},"completionDateStruct":{"date":"2022-09-14","type":"ACTUAL"},"studyFirstSubmitDate":"2020-04-06","studyFirstSubmitQcDate":"2020-04-10","studyFirstPostDateStruct":{"date":"2020-04-14","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-05-23","resultsFirstSubmitQcDate":"2024-02-27","resultsFirstPostDateStruct":{"date":"2024-02-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-02-27","lastUpdatePostDateStruct":{"date":"2024-02-29","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Mochida Pharmaceutical Company, Ltd.","class":"INDUSTRY"},"collaborators":[{"name":"Pfizer","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to verify the efficacy and evaluate the safety of 8-week once-daily oral administration of MD-120 in Japanese patients with depression."},"conditionsModule":{"conditions":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":615,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"MD-120 100 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Desvenlafaxine 100 mg"]},{"label":"MD-120 50 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Desvenlafaxine 50 mg"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Desvenlafaxine 100 mg","description":"once daily dosing for 8 weeks","armGroupLabels":["MD-120 100 mg"]},{"type":"DRUG","name":"Desvenlafaxine 50 mg","description":"once daily dosing for 8 weeks","armGroupLabels":["MD-120 50 mg"]},{"type":"DRUG","name":"Placebo","description":"once daily dosing for 8 weeks","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period","description":"Montgomery-Asberg Depression Rating Scale (MADRS) Total Score: Scale ranges from 0 to 60 with a higher score indicating worsening symptoms of depression. Estimates were based on a Mixed-effects Model for Repeated Measures (MMRM) model with the treatment group, assessment timepoint, and the interaction between the treatment group and assessment timepoint as a factor and total MADRS score at baseline as a covariate.","timeFrame":"8 weeks"},{"measure":"Number of Participants With Adverse Events (AEs)","description":"An adverse event is any undesirable or unintended sign (including abnormal findings in general laboratory tests, body weight, and standard 12-lead ECG), symptom, or disease in a subject given the investigational drug, irrespective of the causal relationship to the investigational drug.","timeFrame":"10 weeks"}],"secondaryOutcomes":[{"measure":"Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period","description":"Hamilton Depression Rating Scale-17 (HAM-D17) Total Score: Scale ranges from 0 to 52 with a higher score indicating worsening symptoms of depression. Estimates were based on a MMRM model with the treatment group, assessment timepoint, and the interaction between the treatment group and assessment timepoint as a factor and total HAM-D17 score at baseline as a covariate.","timeFrame":"8 weeks"},{"measure":"Number of Participants With Adverse Drug Reactions (ADRs)","timeFrame":"10 weeks"},{"measure":"Plasma Concentration of Desvenlafaxine","timeFrame":"Week 2 through week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patient with diagnosis of Major Depressive Disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).\n* Hamilton Depression Rating Scale-17 (HAM-D17) total score of ≥20.\n\nExclusion Criteria:\n\n* Patient who meets DSM-5 criteria of the following disorders for current or past history.\n\nSchizophrenia spectrum and other psychotic disorders Bipolar and related disorders Substance use disorders (exclusive of tobacco and caffeine)\n\n* Patient who had suicidal behavior in Columbia-Suicide Severity Rating Scale (C-SSRS) within 1 year before start of screening phase.","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Koichi Hayashi","affiliation":"Mochida Pharmaceutical Company, Ltd.","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Mochida Investigational sites","city":"Tokyo","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants who met entry criteria were enrolled placebo lead-in period for one week prior to randomization, after that participants randomized and enrolled in one of three treatment group (Placebo group, MD-120 50 mg group, MD-120 100 mg group) for 8 weeks as double-blind treatment period.","recruitmentDetails":"Participants took part in the study at 82 investigational sites in Japan from 18 May 2020 to 14 September 2022.","groups":[{"id":"FG000","title":"Placebo","description":"Placebo, orally, once daily for up to Week 8"},{"id":"FG001","title":"MD-120 50 mg","description":"MD-120 50 mg, orally, once daily for up to Week 8"},{"id":"FG002","title":"MD-120 100 mg","description":"MD-120 50 mg, orally, once daily for up to Week 1, followed by MD-120 100 mg, orally, once daily for up to Week 8"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"204"},{"groupId":"FG001","numSubjects":"207"},{"groupId":"FG002","numSubjects":"204"}]},{"type":"Received Treatment","achievements":[{"groupId":"FG000","numSubjects":"204"},{"groupId":"FG001","numSubjects":"206"},{"groupId":"FG002","numSubjects":"204"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"185"},{"groupId":"FG001","numSubjects":"195"},{"groupId":"FG002","numSubjects":"186"}]},{"type":"NOT 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Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"203"},{"groupId":"BG001","value":"206"},{"groupId":"BG002","value":"204"},{"groupId":"BG003","value":"613"}]}]}]},{"title":"Montgomery Asberg Depression Rating Scale (MADRS) Total Score","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"31.6","spread":"4.9"},{"groupId":"BG001","value":"32.0","spread":"4.7"},{"groupId":"BG002","value":"31.5","spread":"4.7"},{"groupId":"BG003","value":"31.7","spread":"4.8"}]}]}]},{"title":"Hamilton Depression Rating Scale-17 (HAM-D17) Total Score","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Scores on a 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Estimates were based on a Mixed-effects Model for Repeated Measures (MMRM) model with the treatment group, assessment timepoint, and the interaction between the treatment group and assessment timepoint as a factor and total MADRS score at baseline as a covariate.","populationDescription":"Of subjects registered for randomization, those meeting all the following items were included in the full analysis set (FAS).\n\n1. Subjects who received the investigational drug at least once during the treatment period.\n2. Subjects who were evaluated for the total MADRS score at the baseline and at least one timepoint after the start of the treatment period.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Score on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Placebo","description":"Placebo, orally, once daily for up to Week 8"},{"id":"OG001","title":"MD-120 50 mg","description":"MD-120 50 mg, orally, once daily for up to Week 8"},{"id":"OG002","title":"MD-120 100 mg","description":"MD-120 50 mg, orally, once daily for up to Week 1, followed by MD-120 100 mg, orally, once daily for up to Week 8"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"206"},{"groupId":"OG002","value":"204"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-10.4","spread":"0.7"},{"groupId":"OG001","value":"-11.1","spread":"0.7"},{"groupId":"OG002","value":"-11.9","spread":"0.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.","pValue":"0.509","pValueComment":"A priori threshold for statistical significance is p\\<0.05, 2-sided.","statisticalMethod":"MMRM","paramType":"LS mean difference","paramValue":"-0.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.5","ciUpperLimit":"1.2"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.","pValue":"0.131","pValueComment":"A priori threshold for statistical significance is p\\<0.05, 2-sided. The value was based on the post-hoc analysis by not taking into account the multiplicity.","statisticalMethod":"MMRM","paramType":"LS mean difference","paramValue":"-1.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.3","ciUpperLimit":"0.4"}]},{"type":"PRIMARY","title":"Number of Participants With Adverse Events (AEs)","description":"An adverse event is any undesirable or unintended sign (including abnormal findings in general laboratory tests, body weight, and standard 12-lead ECG), symptom, or disease in a subject given the investigational drug, irrespective of the causal relationship to the investigational drug.","populationDescription":"Of subjects registered for randomization, those meeting all the following items will be included in the safety analysis set in treatment period.\n\n1. Subjects who have received the investigational drug at least once during the treatment period.\n2. Subjects in whom the safety evaluation data after the dose of the investigational drug in the treatment period are available.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"10 weeks","groups":[{"id":"OG000","title":"Placebo","description":"Placebo, orally, once daily for up to Week 8"},{"id":"OG001","title":"MD-120 50 mg","description":"MD-120 50 mg, orally, once daily for up to Week 8"},{"id":"OG002","title":"MD-120 100 mg","description":"MD-120 50 mg, orally, once daily for up to Week 1, followed by MD-120 100 mg, orally, once daily for up to Week 8"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"204"},{"groupId":"OG001","value":"206"},{"groupId":"OG002","value":"204"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"124"}]}]}]},{"type":"SECONDARY","title":"Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period","description":"Hamilton Depression Rating Scale-17 (HAM-D17) Total Score: Scale ranges from 0 to 52 with a higher score indicating worsening symptoms of depression. 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25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":204},{"groupId":"EG001","numAffected":1,"numAtRisk":206},{"groupId":"EG002","numAffected":0,"numAtRisk":204}]},{"term":"Clavicle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":204},{"groupId":"EG001","numAffected":0,"numAtRisk":206},{"groupId":"EG002","numAffected":1,"numAtRisk":204}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 25.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":204},{"groupId":"EG001","numAffected":27,"numAtRisk":206},{"groupId":"EG002","numAffected":35,"numAtRisk":204}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 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publish the Study results at any time without the prior written approval of the Sponsor."},"pointOfContact":{"title":"Director of Clinical Research Department","organization":"Mochida Pharmaceutical Company, Ltd.","email":"clinical.trials.contact@mochida.co.jp","phone":"+81332256331"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2020-03-02","uploadDate":"2023-05-17T03:08","filename":"Prot_000.pdf","size":2215560},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2022-09-14","uploadDate":"2023-05-17T03:09","filename":"SAP_001.pdf","size":1029203}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood 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