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
TRIPLE
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 patents at baseline, after 8 weeks.
Time frame: within the first 8 weeks (plus or minus 5 days) after adminitration
IOWA conner's rating scale
Validated questionnaire about core ADHD symptoms(IOWA Conner's rating scale) filled out by parents at baseline, after 2,4 weeks and closeout
Time frame: baseline, after 2, 4, and 8 weeks
Clinical Global Impression(Severity and Improvement)
Clinical Global Impression(Severity and Improvement)rated by treating physician at baseline, after2,4 weeks and closeout
Time frame: baseline, after 2, 4, and 8 weeks
Advanced Test of Attention
Advanced Test of Attention and baseline and closeout Attention Diagnostic system(visual and auditory) at baseline 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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