protocolSection identificationModule nctId: NCT06372964, orgStudyIdInfo id: ITI-007-421, briefTitle: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Intra-Cellular Therapies, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5)., conditionsModule conditions: Bipolar Depression, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 384, type: ESTIMATED, armsInterventionsModule interventions name: Lumateperone, interventions name: Placebo, outcomesModule primaryOutcomes measure: Children's Depression Rating Scale-Revised (CDRS-R), secondaryOutcomes measure: Clinical Global Impression Scale-Severity (CGI-S), eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Anaheim, state: California, zip: 92805, country: United States, geoPoint lat: 33.83529, lon: -117.9145, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Sacramento, state: California, zip: 95817, country: United States, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92103, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Colorado Springs, state: Colorado, zip: 80910, country: United States, geoPoint lat: 38.83388, lon: -104.82136, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Gainesville, state: Florida, zip: 32607, country: United States, geoPoint lat: 29.65163, lon: -82.32483, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Hialeah, state: Florida, zip: 33012, country: United States, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Miami Lakes, state: Florida, zip: 33014, country: United States, geoPoint lat: 25.90871, lon: -80.30866, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Miami Lakes, state: Florida, zip: 33016, country: United States, geoPoint lat: 25.90871, lon: -80.30866, locations facility: Clinical Site, status: RECRUITING, city: Miami Springs, state: Florida, zip: 33166, country: United States, geoPoint lat: 25.82232, lon: -80.2895, locations facility: Clinical Site, status: RECRUITING, city: Orlando, state: Florida, zip: 32803, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30318, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Clinical Site, status: RECRUITING, city: Decatur, state: Georgia, zip: 30030, country: United States, geoPoint lat: 33.77483, lon: -84.29631, locations facility: Clinical Site, status: RECRUITING, city: Lawrenceville, state: Georgia, zip: 30046, country: United States, geoPoint lat: 33.95621, lon: -83.98796, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Savannah, state: Georgia, zip: 31405, country: United States, geoPoint lat: 32.08354, lon: -81.09983, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Baltimore, state: Maryland, zip: 21229, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Saint Charles, state: Missouri, zip: 63304, country: United States, geoPoint lat: 38.78394, lon: -90.48123, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Lincoln, state: Nebraska, zip: 68526, country: United States, geoPoint lat: 40.8, lon: -96.66696, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Kinston, state: North Carolina, zip: 28504, country: United States, geoPoint lat: 35.26266, lon: -77.58164, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Avon Lake, state: Ohio, zip: 44012, country: United States, geoPoint lat: 41.50532, lon: -82.0282, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Cincinnati, state: Ohio, zip: 45219, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Garfield, state: Ohio, zip: 44125, country: United States, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73112, country: United States, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73116, country: United States, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Austin, state: Texas, zip: 78759, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Frisco, state: Texas, zip: 75034, country: United States, geoPoint lat: 33.15067, lon: -96.82361, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77089, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77090, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Bellevue, state: Washington, zip: 98007, country: United States, geoPoint lat: 47.61038, lon: -122.20068, hasResults: False