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SchizophreniaPhase 3NCT06229210

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

A Phase 3 study testing Lumateperone in people with Schizophrenia and Bipolar Disorder, run by Intra-Cellular Therapies, Inc. at 65 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 5 to 17 years
What is being tested?
Lumateperone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
65 sitesin 3 countries
Study dates
25 Jan 2024to 28 Apr 2032
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

65 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

65 sites in 3 countries

United States59 sites, 47 recruiting

  • Advanced Research Center, Inc

    Anaheim, California, 92805

    Recruiting

  • CenExeli Research LLC

    Atlanta, Georgia, 30030

    Recruiting

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

    Recruiting

  • Atlanta Behavioral Research, LLC

    Atlanta, Georgia, 30338

    Completed

  • Quest Therapeutics of Avon Lake

    Avon Lake, Ohio, 44012

    Completed

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

    Recruiting

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan, 48302

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Recruiting

  • MCB Clinical Research Centers LLC

    Colorado Springs, Colorado, 80910

    Completed

  • Texas Research Group

    Coppell, Texas, 75019

    Recruiting

  • Core Clinical Research

    Everett, Washington, 98201

    Recruiting

  • Royal Palm Clinical Research

    Fort Myers, Florida, 33901

    Suspended

  • PsyMed Solutions

    Fort Worth, Texas, 76132

    Recruiting

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

    Recruiting

  • National Institute Of Clinical Research

    Garden Grove, California, 92844

    Recruiting

  • Charak Center for Health and Wellness

    Garfield Heights, Ohio, 44125

    Recruiting

  • United Research Institute

    Hialeah, Florida, 33012

    Recruiting

  • Advanced Research Institute of Miami

    Homestead, Florida, 33033

    Recruiting

  • Kaleidoscope Clinical Research

    Houston, Texas, 77089

    Recruiting

  • Red Oak Psychiatry Associates

    Houston, Texas, 77090

    Recruiting

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana, 46202

    Completed

  • Green Leaf Clinical Trials

    Jacksonville, Florida, 32258

    Recruiting

  • Clinical Research of Southern Nevada, LLC

    Las Vegas, Nevada, 89128

    Recruiting

  • Salveo Integrative Health Inc

    Lawrenceville, Georgia, 30046

    Completed

  • Alivation Research LLC

    Lincoln, Nebraska, 68526

    Recruiting

  • Pillar Clinical Research, LLC

    Little Rock, Arkansas, 72204

    Recruiting

  • Vital Care Research

    Miami, Florida, 33122

    Suspended

  • Columbus Clinical Services LLC

    Miami, Florida, 33125

    Recruiting

  • Care Research Center Inc

    Miami, Florida, 33130

    Recruiting

  • Blue Medical Research

    Miami, Florida, 33144

    Recruiting

  • AP Medical Research

    Miami, Florida, 33165

    Suspended

  • Envision Trials LLC

    Miami, Florida, 33166

    Recruiting

  • GTL Medical and Research Group

    Miami, Florida, 33173

    Completed

  • Diverse Clinical Research LLC

    Miami, Florida, 33175

    Recruiting

  • Links Clinical Trials

    Miami, Florida, 33176

    Recruiting

  • New Med Research Inc

    Miami Gardens, Florida, 33056

    Recruiting

  • The Angel Medical Research Corporation

    Miami Gardens, Florida, 33169

    Recruiting

  • Riveldi Biomedical Research

    Miami Lakes, Florida, 33014

    Recruiting

  • Baber Research Group

    Naperville, Illinois, 60563

    Recruiting

  • Access Clinical Trials

    Nashville, Tennessee, 37203

    Recruiting

  • NYU Child Study Center

    New York, New York, 10016

    Recruiting

  • Excell Research Inc

    Oceanside, California, 92056

    Recruiting

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

    Completed

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73116

    Recruiting

  • APG Research LLC

    Orlando, Florida, 32803

    Suspended

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona, 85006

    Recruiting

  • AIM Trials

    Plano, Texas, 75093

    Recruiting

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

    Recruiting

  • Inland Psychiatric Medical Group Inc

    Redlands, California, 92373

    Recruiting

  • Perceptive Pharma Research

    Richmond, Texas, 77407

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23220

    Recruiting

  • University Of California - Davis

    Sacramento, California, 95817

    Recruiting

  • Midwest Research Group 1

    Saint Charles, Missouri, 63304

    Recruiting

  • University Of California San Diego

    San Diego, California, 92103

    Completed

  • CenExeli Research LLC 1

    Savannah, Georgia, 31405

    Recruiting

  • University of South Florida Rothman Center of Neuropsychiatry

    St. Petersburg, Florida, 33701

    Recruiting

  • Richmond Behavioral Associates

    Staten Island, New York, 10314

    Recruiting

  • Next Level Clinical Trials, LLC

    West Covina, California, 91790

    Recruiting

  • Health Synergy Clinical Research

    West Palm Beach, Florida, 33407

    Recruiting

Other trials in United States

Serbia4 sites, 3 recruiting

  • Clinic of Neurology and Psychiatry for Children and Youth

    Belgrade, 11000

    Recruiting

  • Institute of Mental Health Serbia

    Belgrade, 11000

    Recruiting

  • University Clinical Center NIS

    Niš, 18000

    Recruiting

  • Clinical Center of Vojvodina

    Novi Sad, 21000

    Suspended

Other trials in Serbia

Colombia2 sites, 2 recruiting

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    Barranquilla, 080020

    Recruiting

  • HOMO - ESE Hospital Mental de Antioquia

    Bello, 051053

    Recruiting

Other trials in Colombia

About this study

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

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.

Read the 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.
Being tested
Lumateperone
Keywords
Pediatric
Medical subject headings
Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LumateperoneDrug

    Lumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication

Study groups in NCT06229210
Study groupRoleWhat they receive
LumateperoneExperimentalNot described
Receives: Drug: Lumateperone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Common Adverse Events

    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.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start25 Jan 2024
  3. Primary completion28 Apr 2032 (estimated)
  4. Study completion28 Apr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06229210
Sponsor's protocol ID
ITI-007-321
Other IDs
ITI-007-321, 2023-507068-38-00, 2023
Status last verified
Sep 2026
First submitted
19 Jan 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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