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
- Conditions
- Autism Spectrum Disorder
- Registration Number
- NCT05439616
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 161
Inclusion Criteria:<br><br> - Participants at the time of screening must have a Diagnostic and Statistical Manual<br> of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD, confirmed by Kiddie<br> Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL)<br> administered at screening (Visit 1) by a trained clinician.<br><br> - Participants must have an Aberrant Behavior Checklist, 2nd edition - Community<br> Version - Irritability (ABC-I) subscale score = 18 (Visits 1 and 2).<br><br> - Participants must have a Clinical Global Impressions - Severity - Irritability<br> (CGI-S Irritability) score = 4 at screening (Visits 1 and 2).<br><br>Exclusion Criteria:<br><br> - Participants with diagnosis of intellectual disability (Intelligence quotient < 25).<br><br> - No history of major depressive disorder, bipolar disorder, schizophrenia,<br> schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or<br> psychotic disorder due to another medical condition, as excluded by administration<br> of Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime<br> (K-SADS-PL).<br><br> - History of ASD that is associated with Rett Disorder, Fragile-X Syndrome, or<br> Childhood Disintegrative Disorder.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score
- Secondary Outcome Measures
Name Time Method Percentage of Participants with responder status of Very Much Improved or Much Improved on the Clinical Global Impression- Change Irritability (CGI-C Irritability) Scale;Change from Baseline in Parent-Rated Anxiety Scale for Youth with Autism Spectrum Disorder (PRAS-ASD) Total Score;Change from Baseline in Caregiver Strain Questionnaire Short Form 7-Item (CGSQ SF-7) total score