2026-08-27
minor
Study Status, Contacts/Locations v6
Trial sites expanded: 61 → 64 locations
2026-08-11
minor
2 amendments v4-v5
2 re-verifications since 2026-07-30, no change to tracked fields
2026-07-02
minor
Study Status, Study Design, Contacts/Locations v3
Primary completion date2027-12→2032-04-28
Completion date2027-12→2032-04-28
Enrollment target500→300
Study sites50→61
2025-07-07
minor
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v2
Eligibility criteria-1,811 characters
Inclusion Criteria:
De Novo Patients must meet the following criteria:
Able to provide consent as follows:
The patient's legally au [...] patients aged 13 to 17 years (inclusive) with schizophrenia or; 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, [...] Text Revision (DSM-5-TR) primary diagnosis of schizophrenia or, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Diso [...] [...]
Study description+295 characters
[...] ateperone open-label pediatric PK study (Study ITI-007-030)
Patients with irritability associated with autism spectrum disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-035)
Rollover Patients:
• Patients with bipolar disorder who are enrolling directly from a lead-in efficacy study.
Patients with irritability associated with autism spectrum disorder who are enrolling directly from a lead-in efficacy study.
This study will be conducted as follows:
A Screening Period [...]
Study title+26 characters
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia or, Bipolar Disorder or Autism Spectrum Disorder
2024-01-26
minor
Study Identification, Study Status v1
Start dateestimated 2024-01→confirmed 2024-01-25
Study title-42 characters
An Open-label, Long-Term Safety and Tolerability Trial of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia or Bipolar Disorder
2024-01-19
minor
Original filing