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

300 participants

Start Date

Jan 25, 2024

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Autism Spectrum Disorder Bipolar Disorder

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(61)

Southwest Autism Research and Resource Center

Phoenix, Arizona, United States

Pillar Clinical Research, LLC

Little Rock, Arkansas, United States

Advanced Research Center, Inc

Anaheim, California, United States

National Institute Of Clinical Research

Garden Grove, California, United States

Excell Research Inc

Oceanside, California, United States

Inland Psychiatric Medical Group Inc

Redlands, California, United States

University Of California - Davis

Sacramento, California, United States

University Of California San Diego

San Diego, California, United States

Next Level Clinical Trials, LLC

West Covina, California, United States

MCB Clinical Research Centers LLC

Colorado Springs, Colorado, United States

Royal Palm Clinical Research

Fort Myers, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

United Research Institute

Hialeah, Florida, United States

Advanced Research Institute of Miami

Homestead, Florida, United States

Vital Care Research

Miami, Florida, United States

Columbus Clinical Services LLC

Miami, Florida, United States

Care Research Center Inc

Miami, Florida, United States

Blue Medical Research

Miami, Florida, United States

AP Medical Research

Miami, Florida, United States

Envision Trials LLC

Miami, Florida, United States

GTL Medical and Research Group

Miami, Florida, United States

Diverse Clinical Research LLC

Miami, Florida, United States

Links Clinical Trials

Miami, Florida, United States

New Med Research Inc

Miami Gardens, Florida, United States

The Angel Medical Research Corporation

Miami Gardens, Florida, United States

Riveldi Biomedical Research

Miami Lakes, Florida, United States

APG Research LLC

Orlando, Florida, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

University of South Florida Rothman Center of Neuropsychiatry

St. Petersburg, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

CenExeli Research LLC

Atlanta, Georgia, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Atlanta Behavioral Research, LLC

Atlanta, Georgia, United States

Salveo Integrative Health Inc

Lawrenceville, Georgia, United States

CenExeli Research LLC 1

Savannah, Georgia, United States

Baber Research Group

Naperville, Illinois, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Midwest Research Group 1

Saint Charles, Missouri, United States

Alivation Research LLC

Lincoln, Nebraska, United States

Clinical Research of Southern Nevada, LLC

Las Vegas, Nevada, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Quest Therapeutics of Avon Lake

Avon Lake, Ohio, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Charak Center for Health and Wellness

Garfield Heights, Ohio, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Access Clinical Trials

Nashville, Tennessee, United States

Texas Research Group

Coppell, Texas, United States

PsyMed Solutions

Fort Worth, Texas, United States

Kaleidoscope Clinical Research

Houston, Texas, United States

Red Oak Psychiatry Associates

Houston, Texas, United States

AIM Trials

Plano, Texas, United States

Perceptive Pharma Research

Richmond, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Core Clinical Research

Everett, Washington, United States

Clinic of Neurology and Psychiatry for Children and Youth

Belgrade, Serbia

Institute of Mental Health Serbia

Belgrade, Serbia

University Clinical Center NIS

Niš, Serbia

Clinical Center of Vojvodina

Novi Sad, Serbia

View Full Details on ClinicalTrials.gov

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NCT06229210

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