Mental Disorders
Conditions
Keywords
ADHD(attention Deficit Hyperactivity Disorder)
Brief summary
This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD.
Detailed description
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.
Interventions
DRUGYY-162
YY-162(Ginkgo extract 30mg + Ginseng extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication
DRUGPlacebo
Placebo 1T/ Three times a day (tid) for 8 weeks, PO medication
Sponsors
Yuyu Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Korea-ADHD Rating scale | within the first 8 weeks (plus or minus 5 days) after adminitration | Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by patents at baseline, after 8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOWA conner's rating scale | baseline, after 2, 4, and 8 weeks | Validated questionnaire about core ADHD symptoms(IOWA Conner's rating scale) filled out by parents at baseline, after 2,4 weeks and closeout |
| Clinical Global Impression(Severity and Improvement) | baseline, after 2, 4, and 8 weeks | Clinical Global Impression(Severity and Improvement)rated by treating physician at baseline, after2,4 weeks and closeout |
| Advanced Test of Attention | baseline and 8 weeks | Advanced Test of Attention and baseline and closeout Attention Diagnostic system(visual and auditory) at baseline and closeout |
| children's color trails test and stroop test | baseline and 8 weeks | Children's color trails test and stroop test at baseline and closeout |
| Intelligence test(from KEDI-WISC) | screening and 8 weeks | Intelligence test(from KEDI-WISC)at screening and closeout |
Countries
South Korea
Outcome results
None listed