MedDataX Logo

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

NCT ID: NCT04779177

Last Updated: 2025-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-12

Study Completion Date

2022-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Pediatric

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lumateperone 42 mg once daily for 5 days

Group Type EXPERIMENTAL

Lumateperone 42 mg

Intervention Type DRUG

Lumateperone 42 mg, oral administration

Lumateperone 28 mg once daily for 5 days

Group Type EXPERIMENTAL

Lumateperone 28 mg

Intervention Type DRUG

Lumateperone 28 mg, oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lumateperone 42 mg

Lumateperone 42 mg, oral administration

Intervention Type DRUG

Lumateperone 28 mg

Lumateperone 28 mg, oral administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Intra-Cellular Therapies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Site

Role: PRINCIPAL_INVESTIGATOR

Atlanta, Georgia, United States, 30331

Clinical Site

Role: PRINCIPAL_INVESTIGATOR

Decatur, Georgia, United States, 30030

Clinical Site

Role: PRINCIPAL_INVESTIGATOR

Hollywood, Florida, United States, 33024

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Site

Hollywood, Florida, United States

Site Status

Clinical Site

Atlanta, Georgia, United States

Site Status

Clinical Site

Decatur, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ITI-007-020

Identifier Type: -

Identifier Source: org_study_id