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Study identifier: NCT06372964 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Bipolar Depression  ·  Sponsor: Intra-Cellular Therapies, Inc.

PhasePhase 3
Planned participants384
Who can joinAll sexes, 10 Years to 17 Years
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Study Contact  ·  844-434-4210  ·  Participate-In-This-Study1@its.jnj.com

Always discuss trial participation with your own doctor first.

Locations (68)

Harmonex Neuroscience ResearchDothan, Alabama, United StatesRecruiting
Pillar Clinical Research, LLCLittle Rock, Arkansas, United StatesRecruiting
Advanced Research Center, IncAnaheim, California, United StatesRecruiting
Inland Psychiatric Medical Group IncRedlands, California, United StatesRecruiting
UC Davis Health SystemSacramento, California, United StatesRecruiting
University of California San Diego Medical CenterSan Diego, California, United StatesCompleted
Next Level Clinical Trials, LLCWest Covina, California, United StatesRecruiting
MCB Clinical Research Centers LLCColorado Springs, Colorado, United StatesCompleted
Royal Palm Clinical ResearchFort Myers, Florida, United StatesSuspended
United Research InstituteHialeah, Florida, United StatesCompleted
Advanced Research Institute of MiamiHomestead, Florida, United StatesSuspended
Vital Care ResearchMiami, Florida, United StatesSuspended

+ 56 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06372964