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Completed

NCT Number: NCT04779177

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Pediatric Schizophrenia Spectrum and Other Psychotic Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site, Hollywood, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumateperone 42 mg

Drug

Lumateperone 42 mg, oral administration

Lumateperone 28 mg

Drug

Lumateperone 28 mg, oral administration

Primary outcomes

  1. Pharmacokinetics: Cmax

    Time frame: Day 1 and Day 5

    Maximum plasma concentration of lumateperone

  2. Pharmacokinetics: Tmax

    Time frame: Day 1 and Day 5

    Time of maximum concentration of lumateperone in plasma

  3. 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

  4. 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)

  5. Pharmacokinetics: t1/2

    Time frame: Day 1 and Day 5

    Terminal elimination half-life of lumateperone

  6. Pharmacokinetics: CL/F

    Time frame: Day 1 and Day 5

    Apparent oral clearance of lumateperone

Secondary outcomes

  1. Percentage of Subjects With Treatment-emergent Adverse Events

    Time frame: up to 30 days after last dose, up to a total of 35 days

  2. Change From Baseline in Systolic and Diastolic Blood Pressure

    Time frame: Baseline and Day 6

  3. Change From Baseline in ECG QT Interval

    Time frame: Baseline and Day 6

    QTcF

  4. Change From Baseline in Hemoglobin

    Time frame: Baseline and Day 6

  5. Change From Baseline in White Blood Cell Count

    Time frame: Baseline and Day 6

  6. Change From Baseline in Aspartate Aminotransferase

    Time frame: Baseline and Day 6

  7. Change From Baseline in Alanine Aminotransferase

    Time frame: Baseline and Day 6

  8. Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)

    Time frame: Baseline and Day 6

    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.

Sponsors and collaborators

Lead sponsor

Intra-Cellular Therapies, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2021
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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