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

NCT01201187 | Completed Phase 3 DMC

• 1 other identifier: YY-162
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Mental Disorders

Keywords

ADHD(Attention Deficit Hyperactivity Disorder)

Outcome Measures

Primary Outcomes (1)

• Korea-ADHD Rating scale

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

  from baseline to 8 weeks

Secondary Outcomes (5)

• IOWA Conner's rating scale

  from baseline from 8 weeks

• Clinical global Impression(Severity and Improvement)

  from baseline to 8 weeks

• Advanced Test of Attention

  baseline and 8 weeks

• Children's color trails test and stroop test

  baseline and 8 weeks

• Intelligence test(from KEDI-WISC)

  screening and 8 weeks

Study Arms (2)

YY-162

EXPERIMENTAL

YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication

Drug: YY-162

Placebo

PLACEBO COMPARATOR

Placebo 1T/twice a day(bid) for 8weeks, po medication

Drug: Placebo

Interventions

YY-162 DRUG

YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication

Also known as: Combination of Ginkgo extract and Ginseng extract

YY-162

Placebo DRUG

Placebo 1T/twice a day(bid) for 8weeks, po medication

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuyu Pharma, Inc.: lead

Study Sites (3)

Hallym University Hospital

Anyang-si, 431-070, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, 411-706, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 11394191 RESULT

Related Links

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

MeSH Terms

Conditions

Mental Disorders; Attention Deficit Disorder with Hyperactivity

Interventions

YY162; Asian ginseng

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2010
• First Posted: September 14, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2011
• Last Updated: February 25, 2019

Record last verified: 2010-09

Locations

KR (3)