Status:
COMPLETED
Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD
Lead Sponsor:
AbbVie
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors. Many ASD patients show notably high levels of irritabilit...
Eligibility Criteria
Inclusion
- Participants at the time of screening must have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL) administered at screening (Visit 1) by a trained clinician.
- Participants must have an Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) subscale score ≥ 18 (Visits 1 and 2).
- Participants must have a Clinical Global Impressions - Severity - Irritability (CGI-S Irritability) score ≥ 4 at screening (Visits 1 and 2).
Exclusion
- Participants with diagnosis of intellectual disability (Intelligence quotient \< 25).
- No history of major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition, as excluded by administration of Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL).
- History of ASD that is associated with Rett Disorder, Fragile-X Syndrome, or Childhood Disintegrative Disorder.
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2024
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT05439616
Start Date
July 7 2022
End Date
October 4 2024
Last Update
April 4 2025
Active Locations (36)
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1
Advanced Research Center /ID# 245049
Anaheim, California, United States, 92805
2
Sun Valley Research Center /ID# 243133
Imperial, California, United States, 92251-9401
3
CHOC Children's Hospital /ID# 245577
Orange, California, United States, 92868-4203
4
Pacific Clinical Research Management Group /ID# 243019
Upland, California, United States, 91786