ADHD
Conditions
Interventions
Washout for four days - ATX for one day
Washout for four days - Placebo for one day
Sponsors
Department of Neurosurgery, Jichi Medical University Hospital
International University of Health and Welfare Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects meet the following criteria. (1) Subjects are under 16 years old and more than 4 years old. Regardless of sex and treatment before this trial. (2) Subjects are diagnosed with ADHD based on DSM-IV through an interview with more than two pediatric neurologists. (3) Written informed consent was obtained from the parents of all subjects, and the study was approved by the Ethics Committee of Jichi Medical University Hospital, Japan. (4) The Wechsler Intelligence Scale of Children-Third Edition (WISC-III) full IQ scores of subjects are over 70
Exclusion criteria
Exclusion criteria: (1) Subjects who are diagnosed with anxiety disorder (2) Subjects who are diagnosed with glaucoma (3) Subjects who are diagnosed with hyperthyroidism (4) Subjects who have angina, arrhythmia (5) Subjects who have allergies to ATX (6) Subjects who are diagnosed with tics or Tourette's syndrome, or have family history of Tourette's syndrome (7) Subjects who are diagnosed with severe depression (8) Subjects who are diagnosed with pheochromocytoma (9) Subjects who current or past use of monoamine oxidase inhibitor (MAOI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) fNIRS analysis Comparison of frontal activation (Oxy-Hb) before and after an acute clinical dose of ATX or placebo (90 min after ATX administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| The response of continous administration of ATX on ADHD rating scale and Questionnaire-Children with Difficulties. | — |
Countries
Japan
Contacts
Public ContactEiju Watanabe
Jichi Medical University Neurosurgery
Outcome results
None listed