RECRUITING

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

Conditions

Schizophrenia Bipolar Disorder Autism Spectrum Disorder Pediatric

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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, 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.

Official Title

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

Quick Facts

Study Start:2024-01-25

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06229210

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
* 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

ITI Clinical Trials

CONTACT

646 440-9333

ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

Clinical Site

Phoenix, Arizona, 85006

United States

Clinical Site

Little Rock, Arkansas, 72204

United States

Clinical Site

Anaheim, California, 92805

United States

Clinical Site

Colton, California, 92324

United States

Clinical Site

Garden Grove, California, 92844

United States

Clinical Site

Long Beach, California, 90807

United States

Clinical Site

Redlands, California, 92373

United States

Clinical Site

San Diego, California, 92103

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

Hialeah, Florida, 33012

United States

Clinical Site

Miami Gardens, Florida, 33056

United States

Clinical Site

Miami Lakes, Florida, 33014

United States

Clinical Site

Miami Lakes, Florida, 33016

United States

Clinical Site

Miami Springs, Florida, 33166

United States

Clinical Site

Miami, Florida, 33122

United States

Clinical Site

Miami, Florida, 33125

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

Miami, Florida, 33176

United States

Clinical Site

Orlando, Florida, 32803

United States

Clinical Site

Pompano Beach, Florida, 33060

United States

Clinical Site

West Palm Beach, Florida, 33407

United States

Clinical Site

Atlanta, Georgia, 30331

United States

Clinical Site

Decatur, Georgia, 30030

United States

Clinical Site

Lawrenceville, Georgia, 30046

United States

Clinical Site

Savannah, Georgia, 31405

United States

Clinical Site

Naperville, Illinois, 60563

United States

Clinical Site

Indianapolis, Indiana, 46202

United States

Clinical Site

Bloomfield Hills, Michigan, 48302

United States

Clinical Site

Saint Charles, Missouri, 63304

United States

Clinical Site

Lincoln, Nebraska, 68526

United States

Clinical Site

Las Vegas, Nevada, 89128

United States

Clinical Site

Avon Lake, Ohio, 44012

United States

Clinical Site

Cincinnati, Ohio, 45219

United States

Clinical Site

Garfield, Ohio, 44125

United States

Clinical Site

Oklahoma City, Oklahoma, 73116

United States

Clinical Site

Fort Worth, Texas, 76132

United States

Clinical Site

Houston, Texas, 77090

United States

Clinical Site

Plano, Texas, 75093

United States

Clinical Site

Richmond, Texas, 77407

United States

Clinical Site

Richmond, Virginia, 232220

United States

Clinical Site

Bellevue, Washington, 98007

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 Date2024-01-25

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-01-25

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Pediatric

Additional Relevant MeSH Terms

Schizophrenia
Bipolar Disorder
Autism Spectrum Disorder