[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653110":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":70,"studyPopulation":61,"armGroups":71,"interventions":83,"overallOfficials":61,"centralContacts":95,"locations":61,"responsibleParty":105,"collaborators":61,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":61,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":61,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":132,"whyStopped":61,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":61},{"fullName":5,"class":6},"Bukwang Pharmaceutical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score at Week 8","The MADRS is a 10-item clinician-rated scale used to assess the severity of depressive symptoms. Each item is scored from 0 to 6, with a total score ranging from 0 to 60. Higher scores indicate greater severity of depressive symptoms.","Baseline to Week 8",[14,17,21,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":12},"Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score by Lurasidone Dose (20, 40, or 60 mg)","The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to assess the severity of depressive symptoms. Each item is scored from 0 to 6, resulting in a total score ranging from 0 to 60. Higher scores indicate greater severity of depressive symptoms. Mean change from baseline in MADRS total score at Week 8 will be evaluated for each lurasidone dose group (20, 40, or 60 mg) compared with placebo.",{"measure":18,"description":19,"timeFrame":20},"Change in Montgomery-Åsberg Depression Rating Scale Total Score During the Treatment Period by Lurasidone Dose (20, 40, or 60 mg)","The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to assess the severity of depressive symptoms. Each item is scored from 0 to 6, resulting in a total score ranging from 0 to 60. Higher scores indicate greater severity of depressive symptoms. Mean change in MADRS total score during the treatment period will be evaluated for each lurasidone dose group (20, 40, or 60 mg) compared with placebo.","dose-specific baseline to Week 8",{"measure":22,"description":23,"timeFrame":12},"MADRS Response Rate","The Montgomery-Åsberg Depression Rating Scale (MADRS) total score ranges from 0 to 60, with higher scores indicating greater severity of depressive symptoms. Response is defined as a change in MADRS total score from baseline that meets the prespecified criterion of at least a 50% decrease from baseline.",{"measure":25,"description":26,"timeFrame":12},"MADRS Remission Rate","Proportion of participants with MADRS total score ≤10 at Week 8",{"measure":28,"description":29,"timeFrame":12},"Change From Baseline in Clinical Global Impression-Severity Score","Change from baseline in CGI-S score at Week 8.",{"measure":31,"description":32,"timeFrame":12},"Change From Baseline in Hamilton Anxiety Rating Scale Score","Change from baseline in HAM-A score at Week 8.",{"measure":34,"description":35,"timeFrame":12},"Change From Baseline in 17-Item Hamilton Depression Rating Scale Score","Change from baseline in HAM-D17 score at Week 8.",{"measure":37,"description":38,"timeFrame":12},"Change From Baseline in Sheehan Disability Scale Total and Subscale Scores","Ｃhange from baseline in SDS total and subscale score at Week 8.",[40,44,47,50,53],{"measure":41,"description":42,"timeFrame":43},"Incidence of Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations due to AE","Frequency and proportion of participants experiencing adverse events, serious adverse events, and discontinuations due to adverse events during the study.","Baseline ~ Week8 + 1week Safety Follow-up",{"measure":45,"description":46,"timeFrame":43},"Change From Baseline in Abnormal Involuntary Movement Scale Total Score","The Abnormal Involuntary Movement Scale (AIMS) is a clinician-rated scale used to assess the severity of abnormal involuntary movements. Items assessing abnormal movements are rated from 0 (none) to 4 (severe), with higher scores indicating greater severity of abnormal involuntary movements. Change from baseline in the AIMS total score will be evaluated.",{"measure":48,"description":49,"timeFrame":43},"Change From Baseline in Barnes Akathisia Rating Scale Total Score","The Barnes Akathisia Rating Scale (BARS) is a clinician-rated scale used to assess akathisia. The scale includes objective restlessness, subjective awareness of restlessness, subjective distress related to restlessness, and a general clinical assessment of akathisia. Higher scores indicate greater severity of akathisia. Change from baseline in the BARS total score will be evaluated.",{"measure":51,"description":52,"timeFrame":43},"Change From Baseline in Simpson-Angus Scale Total Score","The Simpson-Angus Scale (SAS) is a 10-item clinician-rated scale used to assess drug-induced parkinsonian symptoms. Each item is scored from 0 to 4, with higher scores indicating greater severity of parkinsonian symptoms. The total score ranges from 0 to 40. Change from baseline in the SAS total score will be evaluated.",{"measure":54,"description":55,"timeFrame":43},"Suicidal Ideation and Suicidal Behavior Assessed by the Columbia-Suicide Severity Rating Scale","The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-administered assessment used to identify and classify suicidal ideation and suicidal behavior. This outcome measure does not report a single C-SSRS total score. The frequency and percentage of participants with protocol-specified categories of suicidal ideation and suicidal behavior will be summarized.",{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":61,"timePerspective":61,"maskingInfo":62},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1 ratio to receive adjunctive lurasidone (20, 40, or 60 mg\u002Fday) or placebo, in addition to ongoing antidepressant therapy, for 8 weeks.","TREATMENT",null,{"masking":63,"maskingDescription":64,"whoMasked":65},"QUADRUPLE","Double-blind: Participant, Care Provider, Investigator, Outcomes Assessor are all masked; Randomization and blinding procedures ensure neither participants nor study staff know treatment assignment until unblinding.",[66,67,68,69],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Major depressive disorder (MDD) is a common psychiatric condition, and many patients fail to achieve adequate improvement with antidepressant monotherapy. Adjunctive therapies are therefore needed to improve outcomes. Lurasidone, an atypical antipsychotic, has shown potential benefit when combined with antidepressants.\n\nThis study will enroll up to 364 adult outpatients aged 19-64 years who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD and demonstrate inadequate response to at least one antidepressant. Participants must have a MADRS score ≥24 and CGI-S score ≥4 at both screening and baseline. After a screening\u002Fwashout period of up to 14 days, subjects will be randomized 1:1 to lurasidone or placebo, in addition to their ongoing antidepressant.\n\nTreatment period: 8 weeks of double-blind therapy, with dose titration allowed in the first 2 weeks and fixed dosing thereafter.\n\nFollow-up: 1 week safety follow-up after last dose.\n\nPrimary objective: To assess whether adjunctive lurasidone significantly improves depressive symptoms compared to placebo, measured by MADRS total score change from baseline to Week 8.\n\nSecondary objectives: To evaluate response and remission rates, functional improvement (SDS), and changes in anxiety and depression severity scales (HAM-A, HAM-D17, CGI-S).\n\nSafety objectives: To monitor adverse events, extrapyramidal symptoms (Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), Simpson-Angus Scale (SAS)), suicidality (Columbia-Suicide Severity Rating Scale (C-SSRS)), laboratory values, electrocardiograms (ECGs), and vital signs.\n\nThis trial will provide important evidence on the role of lurasidone as adjunctive therapy for patients with MDD who do not respond adequately to antidepressant monotherapy.",[72,78],{"label":73,"type":74,"description":61,"interventionNames":75},"Lurasidone + Antidepressant","EXPERIMENTAL",[76,77],"Drug: Lurasidone","Drug: Background Antidepressant Therapy",{"label":79,"type":80,"description":61,"interventionNames":81},"Placebo + Antidepressant","PLACEBO_COMPARATOR",[82,77],"Drug: Placebo",[84,88,91],{"type":85,"name":86,"description":86,"armGroupLabels":87,"otherNames":61},"DRUG","Lurasidone",[73],{"type":85,"name":89,"description":89,"armGroupLabels":90,"otherNames":61},"Placebo",[79],{"type":85,"name":92,"description":93,"armGroupLabels":94,"otherNames":61},"Background Antidepressant Therapy","Background Antidepressant treatment (ADT)",[73,79],[96,101],{"name":97,"role":98,"phone":99,"phoneExt":61,"email":100},"Hyunjeong Kim","CONTACT","+82-2-828-8088","hyun.jeong.kim@bukwang.co.kr",{"name":102,"role":98,"phone":103,"phoneExt":61,"email":104},"Wonjun Seo","+82-2-828-8161","won.jun.seo@bukwang.co.kr",{"type":106,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100653110","phase-3-study-of-lurasidone-as-adjunctive-treatment-in-patients-with-major-depressive-disorder-with-inadequate-response-to-antidepressant-monotherapy-100653110",false,"NCT07781293","Study of Lurasidone as Adjunctive Treatment in Patients With Major Depressive Disorder With Inadequate Response to Antidepressant Monotherapy","Evaluating the Efficacy and Safety of Lurasidone as Adjunctive Therapy in Adult Patients Diagnosed With Major Depressive Disorder Who Have an Inadequate Response to Antidepressant Monotherapy: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial","Inclusion Criteria:\n\n* Signed informed consent prior to participation\n* Outpatients aged 19-64 years\n* Diagnosis of Major Depressive Disorder (MDD) per DSM-5 using MINI; psychotic features allowed\n* Current major depressive episode lasting ≥8 weeks at baseline\n* MADRS total score ≥24 at both screening and baseline\n* CGI-S score ≥4 at both screening and baseline\n* Documented history of antidepressant treatment (ADT) with inadequate response (\\\u003C50% improvement)\n* Currently on one of the protocol-permitted antidepressants at minimum effective dose for ≥6 weeks\n* Agreement to maintain the same background ADT regimen until study completion\n* BMI between 16-40 kg\u002Fm²\n* Willingness to discontinue prohibited psychotropic medications during washout\n* Stable doses of permitted concomitant medications (oral hypoglycemics ≥30 days, thyroid replacement ≥90 days, antihypertensives ≥30 days, lipid-lowering agents ≥30 days before baseline)\n\nExclusion Criteria:\n\n* Lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychotic disorders\n* Diagnosis within past 6 months of panic disorder, generalized anxiety disorder, OCD, PTSD, eating disorder, substance abuse\u002Fdependence (except caffeine\u002Fnicotine), or clinically significant personality disorder\n* ≥25% reduction in MADRS score between screening and baseline\n* Significant suicide risk (per C-SSRS, MADRS item 10 ≥5, recent suicide attempt, or investigator judgment)\n* First major depressive episode onset after age 60\n* Treatment resistance: ≥3 adequate ADT trials without remission, or non-response to antipsychotic augmentation\n* Prior ECT, VNS, rTMS within 5 years or history of ECT failure\n* Known hypersensitivity to lurasidone or excipients\n* Use of prohibited medications (strong CYP3A4 inhibitors\u002Finducers, QTc-prolonging drugs) within 14 days before randomization\n* Prior exposure to lurasidone or investigational CNS drugs (per protocol limits)\n* Pregnancy, breastfeeding, or unwillingness to use effective contraception; positive pregnancy test at screening or baseline\n* Clinically significant ECG abnormalities.\n* Clinically significant laboratory abnormalities that may affect study participation or safety.\n* Clinically significant uncontrolled cardiovascular, hepatic, renal, endocrine, neurological, psychiatric, or other medical conditions that may affect study participation or safety.\n* Prolactin \\>100 ng\u002FmL or pituitary adenoma history\n* Investigator\u002Fsite staff or family members of study personnel\n* Inability to comply with study procedures or anticipated relocation during study\n* More than 2 prior attempts at screening\u002Fwashout for this study","ALL","19 Years","64 Years",{"count":118,"type":119},364,"ESTIMATED","INTERVENTIONAL",[122],"PHASE3","This Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of lurasidone as adjunctive therapy in adult patients with major depressive disorder (MDD) who show an inadequate response to antidepressant monotherapy. Eligible participants will continue their background antidepressant treatment and be randomized to receive either lurasidone (20, 40, or 60 mg\u002Fday) or placebo for 8 weeks. The primary endpoint is the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 8. Secondary endpoints include response and remission rates, changes in Clinical Global Impression-Severity (CGI-S), 17-item Hamilton Depression Rating Scale (HAM-D17), Hamilton Anxiety Rating Scale (HAM-A), and Sheehan Disability Scale (SDS) scores. Safety assessments will include adverse events, laboratory tests, electrocardiograms (ECGs), vital signs, and suicidality monitoring Columbia-Suicide Severity Rating Scale (C-SSRS).",[125,126],"Major Depressive Disorder (MDD)","Major Depressive Disorder With Psychotic Features",[128,129,130,131],"Major Depressive Disorder","Antidepressant Inadequate Response","Adjunctive Therapy","Randomized Double-Blind Placebo-Controlled","NOT_YET_RECRUITING","2026-09-14",{"date":135,"type":136},"2026-09-16","ACTUAL",{"date":138,"type":119},"2026-09-28",{"date":140,"type":119},"2027-10",{"name":5,"class":6}]