SchizophreniaPhase 1NCT04779177

Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

A Phase 1 study testing Lumateperone 42 mg and Lumateperone 28 mg in people with Schizophrenia and Pediatric, run by Intra-Cellular Therapies, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder. Read more about this study

Who is it for?: Ages 13 to 17 years
Conditions the study is for: Schizophrenia, Pediatric
What is being tested?: Lumateperone 42 mg and Lumateperone 28 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 3 sitesUnited States
Study dates: 12 Mar 2021to 30 Jul 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 13 to 17 years
All sexes
No healthy volunteers
Child

Main Inclusion Criteria:

Male or female patients between 13 and 17 years of age, inclusive
Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Free from acute exacerbation of their psychosis for at least 3 months prior to Screening
Clinical Global Impression - Severity (CGI-S) score ≤ 4
Body mass index (BMI) within 2 standard deviations of, age- and gender-specific body measurements (based on CDC Clinical Growth Chart, 2000)
Ability to swallow capsules

Main Exclusion Criteria:

Has a primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder
Reports having experienced suicidal ideation within 6 months prior to Screening, any suicidal behavior within 2 years prior to Screening based on the Columbia-Suicide Severity Rating Scale (C-SSRS), and/or the investigator assesses the patient to be a safety risk to him/herself or others
Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables
History of a clinically significant cardiac disorder and/or abnormal screening electrocardiogram (ECG) or a QT interval corrected for heart rate using Fridericia formula > 450 msec in males or > 470 msec in females

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Clinical Site
Atlanta, Georgia, 30331
Clinical Site
Decatur, Georgia, 30030
Clinical Site
Hollywood, Florida, 33024

Other trials in United States

About this study

Official title: An Open-label Multiple Oral Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lumateperone in Patients, Ages 13 to 17 Years, Diagnosed With Schizophrenia or Schizoaffective Disorder

Conditions: Schizophrenia, Pediatric
Being tested: Lumateperone 42 mg, Lumateperone 28 mg
Medical subject headings: Schizophrenia

What participants receive

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

Lumateperone 42 mgDrug
Lumateperone 42 mg, oral administration
Lumateperone 28 mgDrug
Lumateperone 28 mg, oral administration

Study groups in NCT04779177
Study group	Role	What they receive
Lumateperone 42 mg once daily for 5 days	Experimental	Not described Receives: Drug: Lumateperone 42 mg
Lumateperone 28 mg once daily for 5 days	Experimental	Not described Receives: Drug: Lumateperone 28 mg

What is being measured

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

Pharmacokinetics: Cmax
Maximum plasma concentration of lumateperone
Measured: Day 1 and Day 5
Pharmacokinetics: Tmax
Time of maximum concentration of lumateperone in plasma
Measured: Day 1 and Day 5
Pharmacokinetics: AUC0-t
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
Measured: 0 to 24 hours post-dose on Day 1 and Day 5
Pharmacokinetics: AUC0-tau
Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)
Measured: 0 to 24 hours post-dose on Day 1 and Day 5
Pharmacokinetics: t1/2
Terminal elimination half-life of lumateperone
Measured: Day 1 and Day 5
Pharmacokinetics: CL/F
Apparent oral clearance of lumateperone
Measured: Day 1 and Day 5

Secondary outcomes (8)

Percentage of Subjects With Treatment-emergent Adverse Events
Measured: up to 30 days after last dose, up to a total of 35 days
Change From Baseline in Systolic and Diastolic Blood Pressure
Measured: Baseline and Day 6
Change From Baseline in ECG QT Interval
QTcF
Measured: Baseline and Day 6
Change From Baseline in Hemoglobin
Measured: Baseline and Day 6
Change From Baseline in White Blood Cell Count
Measured: Baseline and Day 6
Change From Baseline in Aspartate Aminotransferase
Measured: Baseline and Day 6
Change From Baseline in Alanine Aminotransferase
Measured: Baseline and Day 6
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
AIMS is a measure of facial and oral movements, extremity movements and trunk movements. The AIMS total score is reported based on 7 items (items 1 through 7). Each item is rated on a scale from none (0) to severe (4). The AIMS total score ranges from 0 to 28. Higher values of total AIMS score indicate increased severity in abnormal movement.
Measured: Baseline and Day 6

Timeline

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

12 Mar 202130 Jul 2022

First posted3 Mar 2021
Study start12 Mar 2021
Primary completion30 Jul 2022
Study completion30 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04779177
Sponsor's protocol ID: ITI-007-020
Status last verified: Oct 2025
First submitted: 26 Feb 2021
Last updated: 12 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Multiple Oral Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lumateperone in Patients, Ages 13 to 17 Years, Diagnosed With Schizophrenia or Schizoaffective Disorder
ClinicalTrials.gov ID: NCT04779177
Acronym / sponsor ID: ITI-007-020
Conditions: Schizophrenia, Pediatric
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
Study start: 12 Mar 2021 (actual)
Primary completion: 30 Jul 2022 (actual)
Study completion: 30 Jul 2022 (actual)
First posted: 3 Mar 2021 (actual)
Results: Posted 12 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lumateperone 42 mg once daily for 5 days	Experimental	Drug: Lumateperone 42 mg
Lumateperone 28 mg once daily for 5 days	Experimental	Drug: Lumateperone 28 mg

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

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
Lumateperone 42 mgLumateperone 42 mg, oral administration	Drug	Lumateperone 42 mg once daily for 5 days
Lumateperone 28 mgLumateperone 28 mg, oral administration	Drug	Lumateperone 28 mg once daily for 5 days

Primary outcome

Pharmacokinetics: Cmax
Time frame: Day 1 and Day 5
Maximum plasma concentration of lumateperone
Pharmacokinetics: Tmax
Time frame: Day 1 and Day 5
Time of maximum concentration of lumateperone in plasma
Pharmacokinetics: AUC0-t
Time frame: 0 to 24 hours post-dose on Day 1 and Day 5
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
Pharmacokinetics: AUC0-tau
Time frame: 0 to 24 hours post-dose on Day 1 and Day 5
Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)
Pharmacokinetics: t1/2
Time frame: Day 1 and Day 5
Terminal elimination half-life of lumateperone
Pharmacokinetics: CL/F
Time frame: Day 1 and Day 5
Apparent oral clearance of lumateperone

8 secondary outcomes

Percentage of Subjects With Treatment-emergent Adverse Events
Time frame: up to 30 days after last dose, up to a total of 35 days
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame: Baseline and Day 6
Change From Baseline in ECG QT Interval
Time frame: Baseline and Day 6
Change From Baseline in Hemoglobin
Time frame: Baseline and Day 6
Change From Baseline in White Blood Cell Count
Time frame: Baseline and Day 6
Change From Baseline in Aspartate Aminotransferase
Time frame: Baseline and Day 6
Change From Baseline in Alanine Aminotransferase
Time frame: Baseline and Day 6
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline and Day 6

Results and safety

Results posted to the registry on 12 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lumateperone 42 mg Once Daily for 5 Days	26	21

Primary outcome: Pharmacokinetics: Cmax

Time frame: Day 1 and Day 5. Mean (Standard Deviation). Unit: ng/mL

Measure	Lumateperone 42 mg Once Daily for 5 Days n = 25
Day 1	19.12 (11.21)
Day 5	23.22 (12.60)

Population analysed: The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC.

Primary outcome: Pharmacokinetics: Tmax

Time frame: Day 1 and Day 5. Median (Full Range). Unit: h

Measure	Lumateperone 42 mg Once Daily for 5 Days n = 25
Day 1	1.000 (0.25 to 6.00)
Day 5	1.000 (0.50 to 4.00)

Primary outcome: Pharmacokinetics: AUC0-t

Time frame: 0 to 24 hours post-dose on Day 1 and Day 5. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Lumateperone 42 mg Once Daily for 5 Days n = 25
Day 1	43.612 (21.404)
Day 5	54.975 (26.992)

Primary outcome: Pharmacokinetics: AUC0-tau

Time frame: 0 to 24 hours post-dose on Day 1 and Day 5. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Lumateperone 42 mg Once Daily for 5 Days n = 22
Day 1	48.158 (20.899)
Day 5	58.437 (27.792)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 30 days after last dose, up to a total of 35 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lumateperone 42 mg Once Daily for 5 Days	0 of 26 (0%)	16 of 26 (61.5%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
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Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
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Not yet recruitingPhase 1
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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. This study is not recruiting at the moment.

Clinical Site principal investigator

Atlanta, Georgia, United States, 30331

Clinical Site principal investigator

Decatur, Georgia, United States, 30030

Clinical Site principal investigator

Hollywood, Florida, United States, 33024

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lumateperone 42 mg and Lumateperone 28 mg in people with Schizophrenia and Pediatric, run by Intra-Cellular Therapies, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics: Cmax (time frame: Day 1 and Day 5). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04779177.

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 12 Nov 2025.