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

This study has been completed.
Sponsor:
Information provided by:
Yuyu Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01201187
First received: September 12, 2010
Last updated: January 9, 2012
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Mental Disorders
 Drug: YY-162
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yuyu Pharma, Inc.:

Primary Outcome Measures:
  • Korea-ADHD Rating scale [ Time Frame: from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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:
  • IOWA Conner's rating scale [ Time Frame: from baseline from 8 weeks ] [ Designated as safety issue: No ]
    Validated questionnaire about core ADHD symptoms(IOWA Conner's ration scale) filled out by parents at baseline, after 2,4 weeks and closeout

  • Clinical global Impression(Severity and Improvement) [ Time Frame: from baseline to 8 weeks ] [ Designated as safety issue: No ]
    Clinical global Impression(Severity and Improvement) rated by treating physician at baseline, after 2,4 weeks and closeout

  • Advanced Test of Attention [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    Advanced Test of Attention at baseline and closeout Attention Diagnostic system (visual and auditory) at baseliner and closeout

  • Children's color trails test and stroop test [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    Children's color trails test and stroop test at baseline and closeout

  • Intelligence test(from KEDI-WISC) [ Time Frame: screening and 8 weeks ] [ Designated as safety issue: No ]
    Intelligence test(from KEDI-WISC) at screening and closeout


Estimated Enrollment: 144
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YY-162
YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication
 Drug: YY-162
YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication
Other Name: Combination of Ginkgo extract and Ginseng extract
Placebo Comparator: Placebo
Placebo 1T/twice a day(bid) for 8weeks, po medication
 Drug: Placebo
Placebo 1T/twice a day(bid) for 8weeks, po medication
Other Name: 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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201187

Locations
Korea, Republic of
Hallym University Hospital
Anyang-si, Korea, Republic of, 431-070
Inje University Ilsan Paik Hospital
Goyang-Si, Korea, Republic of, 411-706
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Yuyu Pharma, Inc.
Investigators
Principal Investigator: Soo-Churl Cho, MD, Ph.D Seoul National University Hospital
Principal Investigator: Hyun Ju Hong, MD,Ph.D Hallym University Hospital
Principal Investigator: EunJin Park, MD Inje University
  More Information

Additional Information:
Effect of the herbal extract combination Panax quinquefolium and Ginkgo biloba on attention-deficit hyperactivity disorder: a pilot study.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Seoul National University Hospital, Department of Internal Medicine
ClinicalTrials.gov Identifier: NCT01201187     History of Changes
Other Study ID Numbers: YY-162
Study First Received: September 12, 2010
Last Updated: January 9, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yuyu Pharma, Inc.:
ADHD(Attention Deficit Hyperactivity Disorder)

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Attention Deficit Disorder with Hyperactivity
 Schizophrenia and Disorders with Psychotic Features
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on June 18, 2013