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

August 27, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Colombia
      • Bello, Colombia, 051053
        • Recruiting
        • HOMO - ESE Hospital Mental de Antioquia
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Institute of Mental Health Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinic of Neurology and Psychiatry for Children and Youth
      • Niš, Serbia, 18000
        • Recruiting
        • University Clinical Center Nis
      • Novi Sad, Serbia, 21000
        • Suspended
        • Clinical Center of Vojvodina
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Southwest Autism Research and Resource Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Pillar Clinical Research, LLC
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center, Inc
      • Garden Grove, California, United States, 92844
        • Recruiting
        • National Institute of Clinical Research
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research Inc
      • Redlands, California, United States, 92373
        • Recruiting
        • Inland Psychiatric Medical Group Inc
      • Sacramento, California, United States, 95817
        • Recruiting
        • University Of California - Davis
      • San Diego, California, United States, 92103
        • Completed
        • University of California San Diego
      • West Covina, California, United States, 91790
        • Recruiting
        • Next Level Clinical Trials, LLC
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Completed
        • MCB Clinical Research Centers LLC
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Suspended
        • Royal Palm Clinical Research
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • Sarkis Clinical Trials
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • United Research Institute
      • Homestead, Florida, United States, 33033
        • Recruiting
        • Advanced Research Institute of Miami
      • Jacksonville, Florida, United States, 32258
        • Recruiting
        • Green Leaf Clinical Trials
      • Miami, Florida, United States, 33176
        • Recruiting
        • Links Clinical Trials
      • Miami, Florida, United States, 33125
        • Recruiting
        • Columbus Clinical Services LLC
      • Miami, Florida, United States, 33175
        • Recruiting
        • Diverse Clinical Research LLC
      • Miami, Florida, United States, 33122
        • Suspended
        • Vital Care Research
      • Miami, Florida, United States, 33130
        • Recruiting
        • Care Research Center Inc
      • Miami, Florida, United States, 33144
        • Recruiting
        • Blue Medical Research
      • Miami, Florida, United States, 33165
        • Suspended
        • AP Medical Research
      • Miami, Florida, United States, 33166
        • Recruiting
        • Envision Trials LLC
      • Miami, Florida, United States, 33173
        • Completed
        • GTL Medical and Research Group
      • Miami Gardens, Florida, United States, 33056
        • Recruiting
        • New Med Research Inc
      • Miami Gardens, Florida, United States, 33169
        • Recruiting
        • The Angel Medical Research Corporation
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Riveldi Biomedical Research
      • Orlando, Florida, United States, 32803
        • Suspended
        • APG Research LLC
      • Pompano Beach, Florida, United States, 33060
        • Recruiting
        • Clinical Research Center of Florida
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • University of South Florida Rothman Center of Neuropsychiatry
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Health Synergy Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30030
        • Recruiting
        • CenExeli Research LLC
      • Atlanta, Georgia, United States, 30338
        • Completed
        • Atlanta Behavioral Research, LLC
      • Lawrenceville, Georgia, United States, 30046
        • Completed
        • Salveo Integrative Health Inc
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • CenExeli Research LLC 1
    • Illinois
      • Naperville, Illinois, United States, 60563
        • Recruiting
        • Baber Research Group
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Completed
        • Riley Hospital for Children at Indiana University Health
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Recruiting
        • Neurobehavioral Medicine Group
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Midwest Research Group 1
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Alivation Research LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Clinical Research of Southern Nevada, LLC
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Child Study Center
      • Staten Island, New York, United States, 10314
        • Recruiting
        • Richmond Behavioral Associates
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Completed
        • Quest Therapeutics of Avon Lake
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
      • Garfield Heights, Ohio, United States, 44125
        • Recruiting
        • Charak Center for Health and Wellness
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Completed
        • Cutting Edge Research Group
      • Oklahoma City, Oklahoma, United States, 73116
        • Recruiting
        • Sooner Clinical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Access Clinical Trials
    • Texas
      • Coppell, Texas, United States, 75019
        • Recruiting
        • Texas Research Group
      • Fort Worth, Texas, United States, 76132
        • Recruiting
        • PsyMed Solutions
      • Houston, Texas, United States, 77090
        • Recruiting
        • Red Oak Psychiatry Associates
      • Houston, Texas, United States, 77089
        • Recruiting
        • Kaleidoscope Clinical Research
      • Plano, Texas, United States, 75093
        • Recruiting
        • AIM Trials
      • Richmond, Texas, United States, 77407
        • Recruiting
        • Perceptive Pharma Research
    • Virginia
      • Richmond, Virginia, United States, 23220
        • Recruiting
        • Virginia Commonwealth University
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
      • Everett, Washington, United States, 98201
        • Recruiting
        • Core Clinical Research

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intra-Cellular Therapies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Intra-Cellular Therapies, Inc. Clinical Trial, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITI-007-321 (Other Identifier: Janssen Research & Development, LLC)
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-507068-38-00 (Registry Identifier: EUCT number)

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.

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