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Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

An Open-label Multiple Oral Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lumateperone in Patients, Ages 13 to 17 Years, Diagnosed With Schizophrenia or Schizoaffective Disorder

NCT04779177•Intra-Cellular Therapies, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

13 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients between 13 and 17 years of age, inclusive
•Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
•Free from acute exacerbation of their psychosis for at least 3 months prior to Screening
•Clinical Global Impression - Severity (CGI-S) score ≤ 4
•Body mass index (BMI) within 2 standard deviations of, age- and gender-specific body measurements (based on CDC Clinical Growth Chart, 2000)
•Ability to swallow capsules

Exclusion Criteria

•Has a primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder
•Reports having experienced suicidal ideation within 6 months prior to Screening, any suicidal behavior within 2 years prior to Screening based on the Columbia-Suicide Severity Rating Scale (C-SSRS), and/or the investigator assesses the patient to be a safety risk to him/herself or others
•Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables
•History of a clinically significant cardiac disorder and/or abnormal screening electrocardiogram (ECG) or a QT interval corrected for heart rate using Fridericia formula \> 450 msec in males or \> 470 msec in females

Locations (3)

Clinical Site

Hollywood, Florida, United States

Clinical Site

Atlanta, Georgia, United States

Clinical Site

Decatur, Georgia, United States

Key Dates

Start Date

March 12, 2021

Primary Completion Date

July 30, 2022

Completion Date

July 30, 2022

Last Updated

November 12, 2025

Enrollment

ACTUAL participants

Conditions

SchizophreniaPediatric

Interventions

Lumateperone 42 mg

DRUG

Lumateperone 28 mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Transcutaneous pO₂ Monitoring in PICU

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Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

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