RecruitingPhase 3NCT06229210

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

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder


Sponsor

Intra-Cellular Therapies, Inc.

Enrollment

500 participants

Start Date

Jan 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the safety and tolerability of a medication called lumateperone in children and teenagers with schizophrenia, bipolar disorder, or autism spectrum disorder. **You may be eligible if...** - You are between 5 and 17 years old (age range varies by diagnosis) - You have a confirmed diagnosis of schizophrenia (ages 13-17), bipolar I or II disorder (ages 10-17), or autism spectrum disorder (ages 5-17) - A parent or legal guardian is willing and able to provide consent, and you are willing to provide your own assent - You meet specific diagnostic criteria as confirmed by a structured interview **You may NOT be eligible if...** - You have a different primary psychiatric diagnosis not listed above - You have significant medical conditions that make participation unsafe - Your caregiver is unable or unwilling to provide written informed consent - You are taking certain medications that could interact with lumateperone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLumateperone

Lumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication


Locations(50)

Clinical Site

Phoenix, Arizona, United States

Clinical Site

Little Rock, Arkansas, United States

Clinical Site

Anaheim, California, United States

Clinical Site

Colton, California, United States

Clinical Site

Garden Grove, California, United States

Clinical Site

Long Beach, California, United States

Clinical Site

Redlands, California, United States

Clinical Site

San Diego, California, United States

Clinical Site

West Covina, California, United States

Clinical Site

Colorado Springs, Colorado, United States

Clinical Site

Gainesville, Florida, United States

Clinical Site

Hialeah, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami Gardens, Florida, United States

Clinical Site

Miami Lakes, Florida, United States

Clinical Site

Miami Lakes, Florida, United States

Clinical Site

Miami Springs, Florida, United States

Clinical Site

Orlando, Florida, United States

Clinical Site

Pompano Beach, Florida, United States

Clinical Site

West Palm Beach, Florida, United States

Clinical Site

Atlanta, Georgia, United States

Clinical Site

Decatur, Georgia, United States

Clinical Site

Lawrenceville, Georgia, United States

Clinical Site

Savannah, Georgia, United States

Clinical Site

Naperville, Illinois, United States

Clinical Site

Indianapolis, Indiana, United States

Clinical Site

Bloomfield Hills, Michigan, United States

Clinical Site

Saint Charles, Missouri, United States

Clinical Site

Lincoln, Nebraska, United States

Clinical Site

Las Vegas, Nevada, United States

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Avon Lake, Ohio, United States

Clinical Site

Cincinnati, Ohio, United States

Clinical Site

Garfield, Ohio, United States

Clinical Site

Oklahoma City, Oklahoma, United States

Clinical Site

Fort Worth, Texas, United States

Clinical Site

Houston, Texas, United States

Clinical Site

Plano, Texas, United States

Clinical Site

Richmond, Texas, United States

Clinical Site

Richmond, Virginia, United States

Clinical Site

Bellevue, Washington, United States

Clinical Site

Everett, Washington, United States

Clinical Site

Belgrade, Serbia

Clinical Site

Niš, Serbia

Clinical Site

Novi Sad, Serbia

View Full Details on ClinicalTrials.gov

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NCT06229210


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