# Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

> **NCT06229210** · PHASE3 · RECRUITING · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 500 (estimated)

## Conditions studied

- Schizophrenia
- Bipolar Disorder
- Autism Spectrum Disorder

## Interventions

- **DRUG:** Lumateperone

## Key facts

- **NCT ID:** NCT06229210
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2024-01-25
- **Primary completion:** 2027-12
- **Final completion:** 2027-12
- **Target enrollment:** 500 (ESTIMATED)
- **Last updated:** 2025-07-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06229210

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06229210, "Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT06229210. Licensed CC0.

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