This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD
This is Double-Blind, two arms, multi-center, Interventional, 8 weeks study starting with YY-162(Combination of Ginkgo extract and Ginseng extract in children with ADHD. Assessment of efficacy and safety will be performed at the baseline, weeks 2,4, and 8. At the first visit, a full psychiatric history, demographic date and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will performed; K-ARS, IOWA Conner's rating scale , CGI-S/I, ATA, Children's color trails test and stroop test, Intelligence test(from KEDI-WISC) and adverse event reporting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
Hallym University Hospital
Anyang-si, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Korea-ADHD Rating scale
Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by parents at baseline, after 2,4 and 8 weeks.
Time frame: from baseline to 8 weeks
IOWA Conner's rating scale
Validated questionnaire about core ADHD symptoms(IOWA Conner's ration scale) filled out by parents at baseline, after 2,4 weeks and closeout
Time frame: from baseline from 8 weeks
Clinical global Impression(Severity and Improvement)
Clinical global Impression(Severity and Improvement) rated by treating physician at baseline, after 2,4 weeks and closeout
Time frame: from baseline to 8 weeks
Advanced Test of Attention
Advanced Test of Attention at baseline and closeout Attention Diagnostic system (visual and auditory) at baseliner and closeout
Time frame: baseline and 8 weeks
Children's color trails test and stroop test
Children's color trails test and stroop test at baseline and closeout
Time frame: baseline and 8 weeks
Intelligence test(from KEDI-WISC)
Intelligence test(from KEDI-WISC) at screening and closeout
Time frame: screening and 8 weeks
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