Loading
Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 25, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06372964). This is a study registration, not published results. Lead sponsor: Intra-Cellular Therapies, Inc.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 384 participants (ESTIMATED). Conditions: Bipolar Depression. Interventions: DRUG: Lumateperone; DRUG: Placebo. Primary outcome measures: Children's Depression Rating Scale-Revised (CDRS-R) , Week 6. Brief summary: 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).