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

Last updated: February 21, 2019
Sponsor: Yuyu Pharma, Inc.
Overall Status: Completed

Phase

3

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Williams Syndrome

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT01201187
YY-162
  • Ages 6-12
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 affectivedisorder 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 signedby one of the parents, parent surrogates, or legal guardian.

  • Subjects who can keep visit schedule and whose parent/ parent surrogates or legalguardian can willingly complete assessments defined in the study protocol

  • Subjects/parents, parent surrogates or legal guardian who can understand theparticipation of the study and voluntarily withdraw from the study at any time

Exclusion

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 oranxiety disorder requiring drug therapy.

  • Subjects who have any history of bipolar disorder, psychotic disorder, and substanceuse disorder, have been diagnosed with a pervasive developmental disorder, organicbrain 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 3months and Ginkgo extract or Ginseng extract within recent 1 month.

  • Subjects who currently have a significant medical conditions (e.g. diseases ofcardiovascular, hepatic, renal, respiratory, glaucoma).

  • Subjects who have abnormalities in the ECG or show clinically significantabnormalities 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

Total Participants: 144
Study Start date:
March 01, 2010
Estimated Completion Date:
April 30, 2011

Study 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.

Connect with a study center

  • Hallym University Hospital

    Anyang-si, 431-070
    Korea, Republic of

    Site Not Available

  • Inje University Ilsan Paik Hospital

    Goyang-Si, 411-706
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

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