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Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

StatusRecruiting
PhasePhase 3
Started2024-05-14
View on ClinicalTrials.gov ↗

Amendment history

2026-08-27
Study Status, Contacts/Locations v7
Study sitesdetails revised at 2 of 68 sites
2026-07-30
Study Status v6
Re-verified, no change to tracked fields
2026-07-22
Study Identification, Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 68 sites
2026-07-02
Study Status, Contacts/Locations v4
Primary completion date2027-04→2031-10-31
Completion date2027-05→2031-10-31
Start date2024-05-13→2024-05-14
Study sites59→68
2025-07-03
Study Status, Contacts/Locations v3
Study sites30→59
Show 2 earlier versions
2024-07-26
Study Status v2
Start dateestimated 2024-04→confirmed 2024-05-13
2024-04-22
Study Status, Conditions, Outcome Measures, Eligibility v1
Eligibility criteria+104 characters
Inclusion Criteria: Able to provide consent as follows: The Legally Authorized Representative (LAR) must provide written, informed consent. The patient must provide written assent; Male or female patients 1310 to 17 years of age, inclusive; Have a Diagnostic and Statis [...] on Item 11 (depressed feelings) at Screening and Baseline; Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at [...] t 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 pat [...]
Secondary endpoints1 entry, revised
Clinical Global Impression Scale-Severity (CGI-S)
Primary endpoints1 entry, revised
Children's Depression Rating Scale-Revised (CDRS-R)
2024-04-15
Original filing
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).
Trial Details
NCT Number NCT06372964
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Bipolar Depression
Enrollment 384 participants
Start Date 2024-05-14
Primary Completion 2031-10-31 (estimated)
Study Completion 2031-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-25