# Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

> **NCT04779177** · PHASE1 · COMPLETED · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 26 (actual)

## Conditions studied

- Schizophrenia
- Pediatric

## Interventions

- **DRUG:** Lumateperone 42 mg
- **DRUG:** Lumateperone 28 mg

## Key facts

- **NCT ID:** NCT04779177
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-03-12
- **Primary completion:** 2022-07-30
- **Final completion:** 2022-07-30
- **Target enrollment:** 26 (ACTUAL)
- **Last updated:** 2025-11-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04779177

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04779177, "Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT04779177. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*