[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610367":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":28,"studyPopulation":17,"armGroups":29,"interventions":42,"overallOfficials":17,"centralContacts":50,"locations":56,"responsibleParty":71,"collaborators":17,"id":73,"slug":17,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":17,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":17,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":17,"overallStatus":59,"whyStopped":17,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Supernus Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.","MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes.","4 weeks",[14],{"measure":15,"description":16,"timeFrame":12},"Change From Baseline to Day 29 in the Clinical Global Impression - Severity of Illness Score (CGI-S).","CGI-S is a single-item clinician rating of the clinician's assessment of the severity of symptoms in relation to the clinician's total experience with patients with that condition. The CGI-I is rated on a 7-point scale from 1 to 7, where 1 = \"normal not at all ill\" and 7 = \"among the most extremely ill patients\". Successful therapy is indicated by a lower overall score.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":24},"TRIPLE",[25,26,27],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of SPN-821 administered twice a week as adjunctive therapy to an approved antidepressant therapy in adult participants with MDD. The study includes a 2-week Screening Period, a 4-week Double blind Treatment Period, and a Safety Follow-up phone call one week after the completion of the Treatment Period.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"SPN-821 2400 mg","EXPERIMENTAL","Three 800 mg oral tablets administered twice a week adjunctive to current antidepressant",[35],"Drug: SPN-821 2400 mg",{"label":37,"type":38,"description":39,"interventionNames":40},"Placebo","PLACEBO_COMPARATOR","Three oral tablets administered twice a week adjunctive to current antidepressant",[41],"Drug: Placebo",[43,47],{"type":44,"name":31,"description":45,"armGroupLabels":46,"otherNames":17},"DRUG","SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling",[31],{"type":44,"name":37,"description":48,"armGroupLabels":49,"otherNames":17},"Matched placebo oral tablets",[37],[51],{"name":52,"role":53,"phone":54,"phoneExt":17,"email":55},"Gianpiera Ceresoli-Borroni, PhD","CONTACT","301-838-2521","gceresoliborroni@supernus.com",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":17},"Collaborative Neuroscience Network","RECRUITING","Garden Grove","California","92845","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-117.94145,33.77391,{"lat":69,"lon":68},{"type":72,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100610367",false,"NCT07226661","Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SPN-821 as an Adjunctive Therapy in Adults With Major Depressive Disorder","Inclusion Criteria:\n\n* Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI\n* Duration of current MDE of at least 8 weeks\n* MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit\n* CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit and Day 1 Visit\n* Stable, therapeutic dose of one of the following protocol-approved ADTs as a monotherapy for ≥ 8 weeks before the Screening Visit and ≥ 10 weeks at the Day 1 Visit. Additionally, inadequate response to the current ADT (less than 50% improvement in depressive symptoms) as confirmed by the ATRQ Investigator administered.\n\nExclusion Criteria:\n\n* MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit\n* History of treatment resistant depression (TRD) defined as 3 or more failed ADTs of adequate dose (per ATRQ) and duration (at least 8 weeks) for the current MDE\n* History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit\n* Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion\n* Lifetime diagnosis of any psychotic disorder including MDD with psychosis, MDD with mixed features, bipolar I\u002FII disorder, bipolar depression, schizophrenia, posttraumatic stress disorder, autism spectrum disorder, or any personality disorder or intellectual disability that would affect the ability of the participant to enroll in the study\n* Diagnosis less then 12 months before screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or any other psychiatric condition that has been the primary focus of treatment, or diagnosis of generalized anxiety disorder less then 6 months before screening.\n* History of cardiovascular, respiratory, gastrointestinal, renal, hepatic, and hematologic disorders, or other medical disorders that could impose undue risk or compromise the study in the Investigator's opinion\n* Clinically significant abnormal result prior to Day 1 Visit per Investigator's judgment or abnormal renal function.\n* Requires treatment with a medication or other substance that is prohibited by the protocol.","ALL","18 Years","70 Years",{"count":83,"type":84},230,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder",[90],"Major Depressive Disorder (MDD)","2026-03-19",{"date":93,"type":94},"2026-03-24","ACTUAL",{"date":96,"type":94},"2026-01-19",{"date":98,"type":84},"2027-01-31",{"name":5,"class":6},1]