Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract in Children With ADHD(Attention Deficit Hyperactivity Disorder)

Yuyu Pharma

Status and phase

Completed

Phase 3

Conditions

Mental Disorders

Treatments

Drug: YY-162

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01536210

YY-162 (b)

Details and patient eligibility

About

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

Full 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.

Enrollment

144 patients

Sex

All

Ages

6 to 15 years old

Volunteers

No Healthy Volunteers

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.