Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Intra-Cellular Therapies, Inc.
Age
13–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
