* To evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder, as measured by change from baseline to endpoint on the irritability subscale of the aberrant behavior checklist (ABC-I). * To evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the treatment of serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder.
1\. Study design \- Multi-national, Multi-center, 52 weeks open label, single arm design
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Medical City
Pasig, Philippines
NOT_YET_RECRUITINGPhilippine Children's Medical Center
Quezon City, Philippines
NOT_YET_RECRUITINGInje University Ilsan Paik Hospital
Ilsan, Gyeonggi-do, South Korea
RECRUITINGirritability subscale of the aberrant behavior checklist
Mean change from baseline to endpoint of Part 1 (week 12)in the caregiver-rated ABC Irritability (ABC-I) subscale score. ABC Scale will be completed by subject
Time frame: Week 12
Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech
ABC Scale will be completed by subject
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 52
Change of CGI-S, CGI-I from baseline
CGI-S, CGI-I scale will be evaluated by investigator
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 52
Change of Behavioral problems from baseline
Behavioral problems scale: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Time frame: Week 12, 52
Change of Adaptive Skills from baseline
Adaptive Skills Scale: Vineland Adaptive Behavior Scale (VABS)
Time frame: week 12, 52
Change of Parental stress from baseline
Parental stress scale: Parenting Stress Index (PSI)
Time frame: Weekk 12, 52
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Samsung Medical Center
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
NOT_YET_RECRUITINGSiriraj Hospital Mahidol University
Bangkok, Thailand
NOT_YET_RECRUITING