Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Intra-Cellular Therapies, Inc.
Conditions:
Schizophrenia
Pediatric
Eligibility:
All Genders
13-17 years
Phase:
PHASE1
Brief 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 d...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04779177
Start Date
March 12 2021
End Date
July 30 2022
Last Update
November 12 2025
Active Locations (3)
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1
Clinical Site
Hollywood, Florida, United States, 33024
2
Clinical Site
Atlanta, Georgia, United States, 30331
3
Clinical Site
Decatur, Georgia, United States, 30030