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

July 7, 2025 updated by: Intra-Cellular Therapies, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Site
      • Niš, Serbia, 18000
        • Recruiting
        • Clinical Site
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Clinical Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Clinical Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Clinical Site
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Clinical Site
      • Colton, California, United States, 92324
        • Not yet recruiting
        • Clinical Site
      • Garden Grove, California, United States, 92844
        • Recruiting
        • Clinical Site
      • Long Beach, California, United States, 90807
        • Not yet recruiting
        • Clinical Site
      • Redlands, California, United States, 92373
        • Recruiting
        • Clinical Site
      • San Diego, California, United States, 92103
        • Recruiting
        • Clinical Site
      • West Covina, California, United States, 91790
        • Recruiting
        • Clinical Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Recruiting
        • Clinical Site
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • Clinical Site
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33122
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33125
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33144
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33175
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33165
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33173
        • Recruiting
        • Clinical Site
      • Miami Gardens, Florida, United States, 33056
        • Recruiting
        • Clinical Site
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Clinical Site
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Clinical Site
      • Miami Springs, Florida, United States, 33166
        • Recruiting
        • Clinical Site
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Clinical Site
      • Pompano Beach, Florida, United States, 33060
        • Recruiting
        • Clinical Site
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Clinical Site
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Clinical Site
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Clinical Site
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Clinical Site
    • Illinois
      • Naperville, Illinois, United States, 60563
        • Recruiting
        • Clinical Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Clinical Site
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Recruiting
        • Clinical Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Clinical Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Clinical Site
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Recruiting
        • Clinical Site
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Clinical Site
      • Garfield, Ohio, United States, 44125
        • Recruiting
        • Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Recruiting
        • Clinical Site
    • Texas
      • Fort Worth, Texas, United States, 76132
        • Recruiting
        • Clinical Site
      • Houston, Texas, United States, 77090
        • Recruiting
        • Clinical Site
      • Plano, Texas, United States, 75093
        • Recruiting
        • Clinical Site
      • Richmond, Texas, United States, 77407
        • Recruiting
        • Clinical Site
    • Virginia
      • Richmond, Virginia, United States, 232220
        • Recruiting
        • Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Clinical Site
      • Everett, Washington, United States, 98201
        • Recruiting
        • Clinical Site

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lumateperone
Drug: Lumateperone
Lumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Common Adverse Events
Time Frame: Up to 6 months
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

January 25, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-007-321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Lumateperone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe