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Study details
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Safety and Tolerability Trial of Lumateperone in Pediatric Patients

Intra-Cellular Therapies, Inc.
NCT IDNCT06229210ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

500

Study length

about 3.9 years

Ages

5–17

Locations

47 sites in AR, AZ, CA +14

About this study

Researchers are testing the safety and tolerability of a medication called lumateperone in children with schizophrenia, bipolar disorder, or autism spectrum disorder. The trial will last for 26 weeks.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Lumateperone
PhasePhase 3
DrugLumateperone
Routeoral
Primary goalIncidence of Common Adverse Events

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low4%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

lumateperone

Drug routes

oral (Oral Capsule)

Endpoints

Primary: Incidence of Common Adverse Events

Body systems

Psychiatry / Mental Health