RECRUITING

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

Conditions

Irritability Associated With Autism Spectrum Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).

Official Title

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

Quick Facts

Study Start:2024-11-22

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06690398

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits. 2. Able to provide consent as follows: 1. The patient's LAR must provide written, informed consent. 2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent. 3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment. 4. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL); 5. ABC-I subscale score of \>18 at Screening and Baseline; 6. CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.	1. Has a primary psychiatric diagnosis other than ASD. Exceptions include: 1. Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. 2. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded). 2. History or current diagnosis of Rett syndrome or Fragile X syndrome; 3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or 1. 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; 2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or 3. The patient is considered to be an imminent danger to themselves or others.

Inclusion Criteria

Exclusion Criteria

1. All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
2. Able to provide consent as follows:
1. The patient's LAR must provide written, informed consent.
2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
4. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
5. ABC-I subscale score of \>18 at Screening and Baseline;
6. CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.

1. Has a primary psychiatric diagnosis other than ASD. Exceptions include:
1. Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
2. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
2. History or current diagnosis of Rett syndrome or Fragile X syndrome;
3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
1. 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;
2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
3. The patient is considered to be an imminent danger to themselves or others.

Contacts and Locations

Study Contact

ITI Clinical Trials

CONTACT

646 440-9333

ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

Clinical Site

Dothan, Alabama, 36303

United States

Clinical Site

Peoria, Arizona, 85382

United States

Clinical Site

Phoenix, Arizona, 85006

United States

Clinical Site

Buena Park, California, 90621

United States

Clinical Site

Corona, California, 92879

United States

Clinical Site

Oceanside, California, 92056

United States

Clinical Site

Upland, California, 91786

United States

Clinical Site

West Covina, California, 91790

United States

Clinical Site

Colorado Springs, Colorado, 80910

United States

Clinical Site

Gainesville, Florida, 32607

United States

Clinical Site

Miami Lakes, Florida, 33016

United States

Clinical Site

Miami Springs, Florida, 33166

United States

Clinical Site

Miami, Florida, 33125

United States

Clinical Site

Miami, Florida, 33175

United States

Clinical Site

Miami, Florida, 33176

United States

Clinical Site

Miami, Florida, 33186

United States

Clinical Site

West Palm Beach, Florida, 33407

United States

Clinical Site

Savannah, Georgia, 31405

United States

Clinical Site

Arlington Heights, Illinois, 60005

United States

Clinical Site

Springfield, Illinois, 62701

United States

Clinical Site

Boston, Massachusetts, 02114

United States

Clinical Site

Saint Charles, Missouri, 63304

United States

Clinical Site

Las Vegas, Nevada, 89128

United States

Clinical Site

Cincinnati, Ohio, 45229

United States

Clinical Site

Garfield, Ohio, 44125

United States

Clinical Site

Westlake, Ohio, 44145

United States

Clinical Site

Nashville, Tennessee, 37203

United States

Clinical Site

Dallas, Texas, 75251

United States

Clinical Site

Frisco, Texas, 75034

United States

Clinical Site

Houston, Texas, 77089

United States

Clinical Site

Plano, Texas, 75093

United States

Clinical Site

Petersburg, Virginia, 23805

United States

Clinical Site

Bellevue, Washington, 98007

United States

Collaborators and Investigators

Sponsor: Intra-Cellular Therapies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-22

Study Completion Date2027-04

Study Record Updates

Study Start Date2024-11-22

Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

Irritability Associated With Autism Spectrum Disorder