nctId: NCT06372964 id: ITI-007-421 briefTitle: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients overallStatus: RECRUITING date: 2024-04 date: 2027-04 date: 2027-05 date: 2024-04-18 date: 2024-04-23 name: Intra-Cellular Therapies, Inc. class: INDUSTRY 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). conditions: Bipolar Depression studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 384 type: ESTIMATED name: Lumateperone name: Placebo measure: Children's Depression Rating Scale-Revised (CDRS-R) measure: Clinical Global Impression Scale-Severity (CGI-S) sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Clinical Site status: NOT_YET_RECRUITING city: Anaheim state: California zip: 92805 country: United States lat: 33.83529 lon: -117.9145 facility: Clinical Site status: NOT_YET_RECRUITING city: Sacramento state: California zip: 95817 country: United States lat: 38.58157 lon: -121.4944 facility: Clinical Site status: NOT_YET_RECRUITING city: San Diego state: California zip: 92103 country: United States lat: 32.71533 lon: -117.15726 facility: Clinical Site status: NOT_YET_RECRUITING city: Colorado Springs state: Colorado zip: 80910 country: United States lat: 38.83388 lon: -104.82136 facility: Clinical Site status: NOT_YET_RECRUITING city: Gainesville state: Florida zip: 32607 country: United States lat: 29.65163 lon: -82.32483 facility: Clinical Site status: NOT_YET_RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Clinical Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States lat: 25.90871 lon: -80.30866 facility: Clinical Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33016 country: United States lat: 25.90871 lon: -80.30866 facility: Clinical Site status: RECRUITING city: Miami Springs state: Florida zip: 33166 country: United States lat: 25.82232 lon: -80.2895 facility: Clinical Site status: RECRUITING city: Orlando state: Florida zip: 32803 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States lat: 33.749 lon: -84.38798 facility: Clinical Site status: RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: Clinical Site status: RECRUITING city: Lawrenceville state: Georgia zip: 30046 country: United States lat: 33.95621 lon: -83.98796 facility: Clinical Site status: NOT_YET_RECRUITING city: Savannah state: Georgia zip: 31405 country: United States lat: 32.08354 lon: -81.09983 facility: Clinical Site status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 facility: Clinical Site status: NOT_YET_RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 facility: Clinical Site status: NOT_YET_RECRUITING city: Baltimore state: Maryland zip: 21229 country: United States lat: 39.29038 lon: -76.61219 facility: Clinical Site status: NOT_YET_RECRUITING city: Saint Charles state: Missouri zip: 63304 country: United States lat: 38.78394 lon: -90.48123 facility: Clinical Site status: NOT_YET_RECRUITING city: Lincoln state: Nebraska zip: 68526 country: United States lat: 40.8 lon: -96.66696 facility: Clinical Site status: NOT_YET_RECRUITING city: Kinston state: North Carolina zip: 28504 country: United States lat: 35.26266 lon: -77.58164 facility: Clinical Site status: NOT_YET_RECRUITING city: Avon Lake state: Ohio zip: 44012 country: United States lat: 41.50532 lon: -82.0282 facility: Clinical Site status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45219 country: United States lat: 39.12713 lon: -84.51435 facility: Clinical Site status: NOT_YET_RECRUITING city: Garfield state: Ohio zip: 44125 country: United States facility: Clinical Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73112 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73116 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Site status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Clinical Site status: NOT_YET_RECRUITING city: Frisco state: Texas zip: 75034 country: United States lat: 33.15067 lon: -96.82361 facility: Clinical Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77089 country: United States lat: 29.76328 lon: -95.36327 facility: Clinical Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77090 country: United States lat: 29.76328 lon: -95.36327 facility: Clinical Site status: NOT_YET_RECRUITING city: Bellevue state: Washington zip: 98007 country: United States lat: 47.61038 lon: -122.20068 hasResults: False