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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuyu Pharma, Inc.

Criteria

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.