RECRUITING

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

Talk to us

Conditions

Irritability Associated With Autism Spectrum Disorder

Quick Navigation

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
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06706674

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 CriteriaExclusion Criteria
  1. 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. 2. Able to provide consent as follows:
  3. 1. The patient's LAR must provide written, informed consent.
  4. 2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
  5. 3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
  6. 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);
  7. 5. ABC-I subscale score of \>18 at Screening and Baseline;
  8. 6. CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.
  1. 1. Has a primary psychiatric diagnosis other than ASD. Exceptions include:
  2. 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.
  3. 2. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
  4. 2. History or current diagnosis of Rett syndrome or Fragile X syndrome;
  5. 3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
  6. 1. At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) 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;
  7. 2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
  8. 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
Little Rock, Arkansas, 72204
United States
Clinical Site
Imperial, California, 92251
United States
Clinical Site
Sacramento, California, 95817
United States
Clinical Site
Sherman Oaks, California, 91403
United States
Clinical Site
New Haven, Connecticut, 06511
United States
Clinical Site
Hialeah, Florida, 33012
United States
Clinical Site
Miami Gardens, Florida, 33056
United States
Clinical Site
Miami Lakes, Florida, 33014
United States
Clinical Site
Miami, Florida, 33122
United States
Clinical Site
Miami, Florida, 33135
United States
Clinical Site
Miami, Florida, 33144
United States
Clinical Site
Miami, Florida, 33165
United States
Clinical Site
Miami, Florida, 33173
United States
Clinical Site
Miami, Florida, 33175
United States
Clinical Site
Orlando, Florida, 32803
United States
Clinical Site
Orlando, Florida, 32809
United States
Clinical Site
Pompano Beach, Florida, 33060
United States
Clinical Site
Atlanta, Georgia, 30318
United States
Clinical Site
Lawrenceville, Georgia, 30046
United States
Clinical Site
Naperville, Illinois, 60563
United States
Clinical Site
Evansville, Indiana, 47713
United States
Clinical Site
Indianapolis, Indiana, 46202
United States
Clinical Site
Boston, Massachusetts, 02115
United States
Clinical Site
Bloomfield Hills, Michigan, 48302
United States
Clinical Site
Saint Louis, Missouri, 63108
United States
Clinical Site
Lincoln, Nebraska, 68526
United States
Clinical Site
Bronx, New York, 10467
United States
Clinical Site
Orangeburg, New York, 10962
United States
Clinical Site
Staten Island, New York, 10314
United States
Clinical Site
Kinston, North Carolina, 28504
United States
Clinical Site
Avon Lake, Ohio, 44012
United States
Clinical Site
Oklahoma City, Oklahoma, 73116
United States
Clinical Site
Charleston, South Carolina, 29425
United States
Clinical Site
Austin, Texas, 78759
United States
Clinical Site
Coppell, Texas, 75019
United States
Clinical Site
Dallas, Texas, 75231
United States
Clinical Site
Fort Worth, Texas, 76014
United States
Clinical Site
Houston, Texas, 77090
United States
Clinical Site
Richmond, Virginia, 23220
United States
Clinical Site
Everett, Washington, 98201
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
Study Completion Date2027-04

Study Record Updates

Study Start Date2024-11
Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

  • Irritability Associated With Autism Spectrum Disorder