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NCT06229210PHASE3Recruiting

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

Intra-Cellular Therapies, Inc.

Start Date

1/25/2024

Completion Date

4/28/2032

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.

Detailed Description

The study will enroll pediatric patients as follows: De Novo Patients: * Patients with schizophrenia, including patients who have previously participated in the lumateperone open-label pediatric pharmacokinetic (PK) study (Study ITI-007-020) * Patients with bipolar disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-030) * Patients with irritability associated with autism spectrum disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-035) Rollover Patients: * Patients with bipolar disorder who are enrolling directly from a lead-in efficacy study. * Patients with irritability associated with autism spectrum disorder who are enrolling directly from a lead-in efficacy study. This study will be conducted as follows: * A Screening Period of up to 2 weeks during which patient eligibility will be assessed. * A 26-week Open-label Treatment Period (OLTP) during which all patients will receive open-label lumateperone once daily. * A 2-week Safety Follow-up (SFU) Period: All patients should return to the clinic for the SFU visit approximately 2 weeks after the last dose of open-label lumateperone.

Eligibility Criteria

Age Range: 5 years to 17 years

Inclusion Criteria: * Able to provide consent as follows: * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent; * The patient must provide written assent to study enrollment; * Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder; * Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). * Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study. Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator. Exclusion Criteria: * Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include: * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary. * In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or * At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit; * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or * At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or * The patient is considered to be an imminent danger to him/herself or others.

Interventions

DRUG

Lumateperone

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Conditions

SchizophreniaBipolar DisorderAutism Spectrum Disorder

Locations

Southwest Autism Research and Resource Center

Phoenix, Arizona 85006

United States

Pillar Clinical Research, LLC

Little Rock, Arkansas 72204

United States

Advanced Research Center, Inc

Anaheim, California 92805

United States

National Institute Of Clinical Research

Garden Grove, California 92844

United States

Excell Research Inc

Oceanside, California 92056

United States

Inland Psychiatric Medical Group Inc

Redlands, California 92373

United States

University Of California - Davis

Sacramento, California 95817

United States

University Of California San Diego

San Diego, California 92103

United States

Next Level Clinical Trials, LLC

West Covina, California 91790

United States

MCB Clinical Research Centers LLC

Colorado Springs, Colorado 80910

United States

Royal Palm Clinical Research

Fort Myers, Florida 33901

United States

Sarkis Clinical Trials

Gainesville, Florida 32607

United States

United Research Institute

Hialeah, Florida 33012

United States

Advanced Research Institute of Miami

Homestead, Florida 33033

United States

Vital Care Research

Miami, Florida 33122

United States

Columbus Clinical Services LLC

Miami, Florida 33125

United States

Care Research Center Inc

Miami, Florida 33130

United States

Blue Medical Research

Miami, Florida 33144

United States

AP Medical Research

Miami, Florida 33165

United States

Envision Trials LLC

Miami, Florida 33166

United States

GTL Medical and Research Group

Miami, Florida 33173

United States

Diverse Clinical Research LLC

Miami, Florida 33175

United States

Links Clinical Trials

Miami, Florida 33176

United States

New Med Research Inc

Miami Gardens, Florida 33056

United States

The Angel Medical Research Corporation

Miami Gardens, Florida 33169

United States

Riveldi Biomedical Research

Miami Lakes, Florida 33014

United States

APG Research LLC

Orlando, Florida 32803

United States

Clinical Research Center of Florida

Pompano Beach, Florida 33060

United States

University of South Florida Rothman Center of Neuropsychiatry

St. Petersburg, Florida 33701

United States

Health Synergy Clinical Research

West Palm Beach, Florida 33407

United States

CenExeli Research LLC

Atlanta, Georgia 30030

United States

Atlanta Center for Medical Research

Atlanta, Georgia 30331

United States

Atlanta Behavioral Research, LLC

Atlanta, Georgia 30338

United States

Salveo Integrative Health Inc

Lawrenceville, Georgia 30046

United States

CenExeli Research LLC 1

Savannah, Georgia 31405

United States

Baber Research Group

Naperville, Illinois 60563

United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana 46202

United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan 48302

United States

Midwest Research Group 1

Saint Charles, Missouri 63304

United States

Alivation Research LLC

Lincoln, Nebraska 68526

United States

Clinical Research of Southern Nevada, LLC

Las Vegas, Nevada 89128

United States

Richmond Behavioral Associates

Staten Island, New York 10314

United States

Quest Therapeutics of Avon Lake

Avon Lake, Ohio 44012

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Charak Center for Health and Wellness

Garfield Heights, Ohio 44125

United States

Cutting Edge Research Group

Oklahoma City, Oklahoma 73116

United States

Sooner Clinical Research

Oklahoma City, Oklahoma 73116

United States

Access Clinical Trials

Nashville, Tennessee 37203

United States

Texas Research Group

Coppell, Texas 75019

United States

PsyMed Solutions

Fort Worth, Texas 76132

United States

Kaleidoscope Clinical Research

Houston, Texas 77089

United States

Red Oak Psychiatry Associates

Houston, Texas 77090

United States

AIM Trials

Plano, Texas 75093

United States

Perceptive Pharma Research

Richmond, Texas 77407

United States

Virginia Commonwealth University

Richmond, Virginia 23220

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Core Clinical Research

Everett, Washington 98201

United States

Clinic of Neurology and Psychiatry for Children and Youth

Belgrade, 11000

Serbia

Institute of Mental Health Serbia

Belgrade, 11000

Serbia

University Clinical Center NIS

Niš, 18000

Serbia

Clinical Center of Vojvodina

Novi Sad, 21000

Serbia