A Phase ?, Randomized, Double-Blind, Placebo-control, Dose-Finding, Efficacy and Safety of YY-162 in Patients with ADHD(Attention Deficit Hyperactivity Disorder)

Yuyu Phama0 个研究点目标入组 144 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1. Mele and female subjects aged from 6 to 15
•2. Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K)interview
•3. Subjects signed a written consent form voluntarily
•4. Patient's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates or legal guardian.
•5. Subjects who can keep visit schedule and whose parent/parent surrogates or legal guardian can willingly complete assessments defined in the study protocol.
•6. Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time.

•1. Subjects who have difficulty swallowing tablet.
•2. Subjects who have known allergy to plant extracts.
•3. Subjects who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy.
•4. 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.
•5. Subjects who have significant suicidal ideation.
•6. Subjects with mental retardation.
•7. Subjects with Tourette's syndrome requiring drug therapy.
•8. Subjects who have been administrated Methylphenidate or Atomoxetine within recent 3 months and Ginkgo extract or Ginseng extract within recent 1 month.
•9. Subjects who currently have a significant medical conditions(e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma)
•10. Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results including serum chemistries and hematology.
•11. subjects who are currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant.
•12. subjects who receive psychosocial treatment during the drug trial.
•13. Subjects who are not able to swallow the study drug.

发起方

Yuyu Phama