Clinical trial NCT01536210: Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract in Children With ADHD(Attention Deficit Hyperactivity Disorder)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mental Disorders
Keywords: ADHD(attention Deficit Hyperactivity Disorder)
Lead sponsor: Yuyu Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-20
Enrollment: 144
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 criteria: 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.

Primary outcomes:
measure: Korea-ADHD Rating scale
timeFrame: within the first 8 weeks (plus or minus 5 days) after adminitration
Secondary outcomes:
measure: IOWA conner's rating scale
timeFrame: baseline, after 2, 4, and 8 weeks
measure: Clinical Global Impression(Severity and Improvement)
timeFrame: baseline, after 2, 4, and 8 weeks
measure: Advanced Test of Attention
timeFrame: baseline and 8 weeks
measure: children's color trails test and stroop test
timeFrame: baseline and 8 weeks
measure: Intelligence test(from KEDI-WISC)
timeFrame: screening and 8 weeks
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Hospital
city: Goyang-Si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: SooChurl Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Hospital
name: HyunJu Hong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: EunJin Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.