Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract in Children With ADHD(Attention Deficit Hyperactivity Disorder)

Study Overview
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Brief Summary
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This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD.

Detailed Description
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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.

Official Title
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Randomized, Double-Blind, Placebo-control, Multicenter Study, the Efficacy and Safety of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD(Attention Deficit Hyperactivity Disorder)in 8 Weeks

Conditions
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Mental Disorders

Intervention / Treatment
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* Drug: YY-162
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mele and female subjects aged from 6 to 15 Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K)interview Subjects signed a written consent form voluntarily Patient's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates or legal guardian. Subjects who can keep visit schedule and whose parent/parent surrogates or legal guardian can willingly complete assessments defined in the study protocol. Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time. Exclusion Criteria: Subjects who have difficulty swallowing tablet. Subjects who have known allergy to plant extracts. Subjects who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy. Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder. Subjects who have significant suicidal ideation. Subjects with mental retardation. Subjects with Tourette's syndrome requiring drug therapy. Subjects who have been administrated Methylphenidate or Atomoxetine within recent 3 months and Ginkgo extract or Ginseng extract within recent 1 month. Subjects who currently have a significant medical conditions(e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma) Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results including serum chemistries and hematology. subjects who are currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant. subjects who receive psychosocial treatment during the drug trial. Subjects who are not able to swallow the study drug.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YY-162<br>YY-162(Ginkgo Extract 30mg + Ginseng Extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication | Drug: YY-162<br>* YY-162(Ginkgo extract 30mg + Ginseng extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication<br>* Other names: combination of Ginkgo extract and Ginseng extract;|
| Placebo Comparator: Placebo<br>Placebo 1T /Three times a day(Tid) for 8 weeks, PO medication | Drug: Placebo<br>* Placebo 1T/ Three times a day (tid) for 8 weeks, PO medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korea-ADHD Rating scale | Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by patents at baseline, after 8 weeks. | within the first 8 weeks (plus or minus 5 days) after adminitration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | baseline and 8 weeks | 
| children's color trails test and stroop test | Children's color trails test and stroop test at baseline and closeout | baseline and 8 weeks | 
| Intelligence test(from KEDI-WISC) | Intelligence test(from KEDI-WISC)at screening and closeout | screening and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD(attention Deficit Hyperactivity Disorder)