Status and phase
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About
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
Full description
The study will enroll pediatric patients as follows:
De Novo Patients:
Rollover Patients:
This study will be conducted as follows:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Able to provide consent as follows:
Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder;
Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.
Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.
Exclusion criteria
Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
Primary purpose
Allocation
Interventional model
Masking
500 participants in 1 patient group
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Central trial contact
ITI Clinical Trials
Data sourced from clinicaltrials.gov
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