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.
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
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
- 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
- Are there results?
- Not yet: the study is under way
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.
65 sites in 3 countries
United States59 sites, 47 recruiting
- Recruiting
Advanced Research Center, Inc
Anaheim, California, 92805
- Recruiting
CenExeli Research LLC
Atlanta, Georgia, 30030
- Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
- Completed
Atlanta Behavioral Research, LLC
Atlanta, Georgia, 30338
- Completed
Quest Therapeutics of Avon Lake
Avon Lake, Ohio, 44012
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
- Recruiting
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Completed
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, 80910
- Recruiting
Texas Research Group
Coppell, Texas, 75019
- Recruiting
Core Clinical Research
Everett, Washington, 98201
- Suspended
Royal Palm Clinical Research
Fort Myers, Florida, 33901
- Recruiting
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
- Completed
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
- Recruiting
Green Leaf Clinical Trials
Jacksonville, Florida, 32258
- Recruiting
Clinical Research of Southern Nevada, LLC
Las Vegas, Nevada, 89128
- Completed
Salveo Integrative Health Inc
Lawrenceville, Georgia, 30046
- Recruiting
Alivation Research LLC
Lincoln, Nebraska, 68526
- Recruiting
Pillar Clinical Research, LLC
Little Rock, Arkansas, 72204
- Suspended
Vital Care Research
Miami, Florida, 33122
- Recruiting
Columbus Clinical Services LLC
Miami, Florida, 33125
- Recruiting
Care Research Center Inc
Miami, Florida, 33130
- Recruiting
Blue Medical Research
Miami, Florida, 33144
- Suspended
AP Medical Research
Miami, Florida, 33165
- Recruiting
Envision Trials LLC
Miami, Florida, 33166
- Completed
GTL Medical and Research Group
Miami, Florida, 33173
- Recruiting
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
Sooner Clinical Research
Norman, Oklahoma, 73071
- Recruiting
Excell Research Inc
Oceanside, California, 92056
- Completed
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
- Suspended
APG Research LLC
Orlando, Florida, 32803
- Recruiting
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
- Completed
University Of California San Diego
San Diego, California, 92103
- Recruiting
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
Serbia4 sites, 3 recruiting
- 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
- Suspended
Clinical Center of Vojvodina
Novi Sad, 21000
Colombia2 sites, 2 recruiting
- Recruiting
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, 080020
- Recruiting
HOMO - ESE Hospital Mental de Antioquia
Bello, 051053
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.
- Conditions
- Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Lumateperone | Experimental | Not described Receives: Drug: Lumateperone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted29 Jan 2024
- Study start25 Jan 2024
- Primary completion28 Apr 2032 (estimated)
- Study completion28 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Intra-Cellular Therapies, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Intra-Cellular Therapies, Inc. Clinical Trial, Study director, Intra-Cellular Therapies, Inc.
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
- Nov 2026
- First submitted
- 19 Jan 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06229210
- Acronym / sponsor ID
- ITI-007-321
- Conditions
- Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
- Keywords
- Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 28 Apr 2032 (estimated)
- Study completion
- 28 Apr 2032 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumateperone | Experimental | Drug: Lumateperone |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Able to provide consent as follows:
- 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.
Key exclusion criteria (8 listed)
- 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:
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumateperoneLumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication | Drug | Lumateperone |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Intra-Cellular Therapies, Inc. Clinical Trial study director
Intra-Cellular Therapies, Inc.
65 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Serbia, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Common Adverse Events (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.