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

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

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

Study Overview

• Status: Completed
• Conditions: Mental Disorders
• Intervention / Treatment: Drug: YY-162; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang-si, Korea, Republic of, 431-070
    • Hallym University Hospital
  • Goyang-Si, Korea, Republic of, 411-706
    • Inje University Ilsan Paik Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yuyu Pharma, Inc.
• Investigators: Principal Investigator: SooChurl Cho, MD, PhD, Seoul National University Hospital; Principal Investigator: HyunJu Hong, MD, PhD, Hallym University Hospital; Principal Investigator: EunJin Park, MD, Inje University

Publications and helpful links

General Publications

• Lyon MR, Cline JC, Totosy de Zepetnek J, Shan JJ, Pang P, Benishin C. Effect of the herbal extract combination Panax quinquefolium and Ginkgo biloba on attention-deficit hyperactivity disorder: a pilot study. J Psychiatry Neurosci. 2001 May;26(3):221-8.

Helpful Links

• Effect of the herbal extract combination Panax quinquifolius and Ginkgo biloba on attention-deficit hyperactivity disorder: a pilot study

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 20, 2012

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: ADHD(attention Deficit Hyperactivity Disorder)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Mental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: YY-162 (b)