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

Phase 3

Completed

• Conditions: Mental Disorders
• Interventions: Drug: Placebo; Drug: YY-162

• Registration Number: NCT01536210
• Lead Sponsor: Yuyu Pharma, Inc.

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-20
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 1T /Three times a day(Tid) for 8 weeks, PO medication
YY-162	YY-162	YY-162(Ginkgo Extract 30mg + Ginseng Extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Hallym University Hospital; 🇰🇷 Anyang-si, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang-Si, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of