MedTrace Logo

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

NCT04779177 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-11-12

Study results available
· View outcomes & findings →

Summary

Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.

Conditions

Interventions

DRUG

Lumateperone 28 mg

Lumateperone 28 mg, oral administration

DRUG

Lumateperone 42 mg

Lumateperone 42 mg, oral administration

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Site · Atlanta, Georgia, United States, 30331

  • Clinical Site · Decatur, Georgia, United States, 30030

  • Clinical Site · Hollywood, Florida, United States, 33024

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2022-07-30
Completion
2022-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04779177 on ClinicalTrials.gov