Status:
COMPLETED
Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD
Lead Sponsor:
Yuyu Pharma, Inc.
Conditions:
Mental Disorders
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
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 saf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01201187
Start Date
March 1 2010
End Date
April 1 2011
Last Update
February 25 2019
Active Locations (3)
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1
Hallym University Hospital
Anyang-si, South Korea, 431-070
2
Inje University Ilsan Paik Hospital
Goyang-si, South Korea, 411-706
3
Seoul National University Hospital
Seoul, South Korea, 110-744