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Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:\n\n   * Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study.\n2. Intellectual disability based on Investigator opinion and DSM-5 criteria\n3. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;\n4. Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;\n5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his\u002Fher participation in the study or\n\n   1. At Screening, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;\n   2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or\n   3. At Screening or Baseline, scores \\> 3 on Item 13 (suicidal ideation) on the CDRS-R; or\n   4. The patient is considered to be an imminent danger to him\u002Fherself or others.","ALL","10 Years","17 Years",{"count":644,"type":645},384,"ESTIMATED","INTERVENTIONAL",[648],"PHASE3","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).",[651],"Bipolar Depression","2026-07-30",{"date":654,"type":655},"2026-07-31","ACTUAL",{"date":657,"type":655},"2024-05-14",{"date":659,"type":645},"2031-10-31",{"name":5,"class":6},68]