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

Mental Disorders Clinical Trial

— yuyu  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201187
• Other study ID #: YY-162
• Status: Completed
• Phase: Phase 3
• Start date: March 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2010
• Source: Yuyu Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Hospital	Anyang-si
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-Si
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuyu Pharma, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IOWA Conner's rating scale	Validated questionnaire about core ADHD symptoms(IOWA Conner's ration scale) filled out by parents at baseline, after 2,4 weeks and closeout	from baseline from 8 weeks
Secondary	Clinical global Impression(Severity and Improvement)	Clinical global Impression(Severity and Improvement) rated by treating physician at baseline, after 2,4 weeks and closeout	from baseline to 8 weeks
Secondary	Advanced Test of Attention	Advanced Test of Attention at baseline and closeout Attention Diagnostic system (visual and auditory) at baseliner and closeout	baseline and 8 weeks
Secondary	Children's color trails test and stroop test	Children's color trails test and stroop test at baseline and closeout	baseline and 8 weeks
Secondary	Intelligence test(from KEDI-WISC)	Intelligence test(from KEDI-WISC) at screening and closeout	screening and 8 weeks

External Links

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