Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD

Phase 3

Completed

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

• Registration Number: NCT01201187
• 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: 2010-03
• Primary Completion: 2010-04
• Status Verified: 2010-09
• Study First Submitted: 2010-09-12
• Study First Submitted QC: 2010-09-12
• Study First Posted: 2010-09-14
• Study Completion: 2011-04
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

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

Inclusion Criteria

• Male and female subjects aged from 6 to 12
• 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/twice a day(bid) for 8weeks, po medication
YY-162	YY-162	YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication

Primary Outcome Measures

Name	Time	Method
Korea-ADHD Rating scale	from baseline to 8 weeks	Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by parents at baseline, after 2,4 and 8 weeks.

Secondary Outcome Measures

Name	Time	Method
IOWA Conner's rating scale	from baseline from 8 weeks	Validated questionnaire about core ADHD symptoms(IOWA Conner's ration scale) filled out by parents at baseline, after 2,4 weeks and closeout
Advanced Test of Attention	baseline and 8 weeks	Advanced Test of Attention at baseline and closeout Attention Diagnostic system (visual and auditory) at baseliner and closeout
Intelligence test(from KEDI-WISC)	screening and 8 weeks	Intelligence test(from KEDI-WISC) at screening and closeout
Clinical global Impression(Severity and Improvement)	from baseline to 8 weeks	Clinical global Impression(Severity and Improvement) rated by treating physician at baseline, after 2,4 weeks 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

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