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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 5 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  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 (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; 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lumateperone high dose 		Lumateperone 42 mg for patients ages 13-17 years old
  • Drug: Lumateperone high dose
    Lumateperone administered orally once daily
Experimental
Lumateperone low dose 		Lumateperone 21 mg for patients ages 13-17 years old
  • Drug: Lumateperone low dose
    Lumateperone administered orally once daily
Placebo Comparator
Placebo 		Placebo
  • Drug: Placebo
    Matching Placebo administered orally once daily

Recruiting Locations

Pillar Clinical Research, LLC
Little Rock, Arkansas 72204

University Of California - Davis
Sacramento, California 95817

California Neuroscience Research
Sherman Oaks, California 91403

Yale University School Of Medicine
New Haven, Connecticut 06519

United Research Institute
Hialeah, Florida 33012

Care Research Center Inc
Miami, Florida 33130

Blue Medical Research
Miami, Florida 33144

New Med Research Inc
Miami Gardens, Florida 33056

APG Research LLC
Orlando, Florida 32803

Clinical Research Center of Florida
Pompano Beach, Florida 33060

University of South Florida Rothman Center of Neuropsychiatry
St. Petersburg, Florida 33701

Advanced Discovery Research
Atlanta, Georgia 30318

Salveo Integrative Health Inc
Lawrenceville, Georgia 30046

EmVenio Research at Chicago
Chicago, Illinois 60622

Baber Research Group
Naperville, Illinois 60563

Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana 71101

Neurobehavioral Medicine Group
Bloomfield Hills, Michigan 48302

Alivation Research LLC
Lincoln, Nebraska 68526

NYU Child Study Center
New York, New York 10016

Nathan Kline Institute
Orangeburg, New York 10962

Richmond Behavioral Associates
Staten Island, New York 10314

Advantage Clinical Trials
The Bronx, New York 10467

Quest Therapeutics of Avon Lake
Avon Lake, Ohio 44012

SP Research, PLLC (dba Rivus Wellness & Research Institute)
Oklahoma City, Oklahoma 73112

Sooner Clinical Research
Oklahoma City, Oklahoma 73116

Medical University of South Carolina
Charleston, South Carolina 29425

BioBehavioral Research of Austin PC
Austin, Texas 78759

Red Oak Psychiatry Associates
Houston, Texas 77090

Virginia Commonwealth University
Richmond, Virginia 23220

Core Clinical Research
Everett, Washington 98201

More Details

Status
Recruiting
Sponsor
Intra-Cellular Therapies, Inc.

Study Contact

ITI Clinical Trials
646 440-9333
ITCIClinicalTrials@itci-inc.com

Detailed Description

The study will be conducted in 3 phases: - Screening Period (up to 14 days) during which patient eligibility will be assessed. - Double-blind Treatment Period (DBTP) (6 weeks) during which all patients will be randomized in a 1:1:1 ratio to receive either lumateperone high dose, lumateperone low dose, or placebo as a once daily dose. - Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately 1 week after the last dose of study drug.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.