Attention deficit hyperactivity disorder
Conditions
Interventions
MPH (one day) =>
washout (1week) =>
placebo (one day) =>
MPH (4-8-weeks) =>
1-y continuous administration of MPH (drug naive ADHD group)(as an ancillary study)
placebo (one day)=>
MPH (4-8-weeks) =>
1-y continuous administration of MPH (drug naive ADHD group)(as an ancillary study)
Sponsors
University of Tokyo Medical School The department of Psychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A diagnose child in this study must meet all of the following criteria 1.A child who is an outpatient under 12 years old more than 6 years old when their parents or guardian give written informed consent. Regardless of sex and treatment before this trial. 2.A child who is diagnosed with AD/HD (as any one of three subtypes of AD/HD based on DSM-IV: 314.00 or 314.01) through an interview with either their parents or guardian within 180 days before this trial starts. 3.A child who gives written informed consent signed by either his/her parents or guardian. If possible, the child assesses the informed consent him- or herself. 4.A child who can come to our hospital and participate this trial according to the schedule, and both either his/her parents or guardian or school teacher can answer the questionnaire according to the schedule. In addition, either his/her parents or guardian need to explain the content of this trial to the school teacher his- or her self by using the prepared application format.
Exclusion criteria
Exclusion criteria: 1.A child who is judged that he/she cannot obey and understand the instruction of this trial by the investigator. 2.A child who weighs under 20kg. 3.A child who is diagnosed now with critical undesirable diseases to this trial. 4.A child who has abnormalin the examination of 12-lead electrocardiogram. 5.A child who has abnormal blood pressure. 6.A child who is judged by the investigator or subinvestigator of this trial that he/she has inadequate score in clinical examination. 7.A child who is diagnosed now with glaucoma, thyroidal dysfunction or epilepsia, or has a previous history of those diseases. 8.A child who is diagnosed now with a motor tic, or the Tourette's syndrome or has a previous or first-degree family history of Tourette's syndrome. 9.A child who has a depression that needed a prompt medical treatment of them. 10.A child who is diagnosed as his/her main disorder with an oppositional defiant disorder, conduct disorder. 11.A child who is judged that he/she cannot obey and/or understand the instruction of this trial because he/she has both an impaired coordination and a learning disability. 12.A child who has a full IQ score calculated by WISC-3 less than 70 points. , 13.A child who starts a training program after the day of IC acquisition or finishes it before the end of this trial. 14.The child who has taken the medicine in the dosage exceeding a 60mg/day MPH now. 15.A child whom hypersensitivity to MPH was shown. Or a child who was judged to have serious side-effects of MPH. 16.A child who takes a medicine that combination is prohibited or he/she is judged to need to take it within 7 days before the first day of the behavioral assessment. 17.The child who has drug abuse, drug intoxication, alcoholism, or first-degree family history of those diseases 18.A girl who has her first menstrual period before the start of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Whether an NIRS signal taken before drug administration can predict the effect of the drug after continuous administration (CGI-S) in the drug naive ADHD group (Part A + Part C). 2) Whether the change in the NIRS signal from a baseline measurement to a measurement taken after a single dose can predict drug efficacy after 4-8 weeks of continuous administration (CGI-S) in the drug naive ADHD group (Part A, Part B, Part C). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The effect of a single dose of the true drug and a placebo on NIRS signals (Part B). 2) The effect of continuous administration of the drug on NIRS signals (Part C). 3) The differences in NIRS signals (baseline, single dose, after continuous administration) between the drug naive ADHD group and the ADHD group with treatment history (Part A, Part B, Part C). 4) Whether the change in the NIRS signal from a baseline measurement to a measurement taken after a single dose can predict drug efficacy after 1 year of continuous administration (CGI-S) in the drug naive ADHD group (Part A, Part B, Part D). 5) Changes in the NIRS signal in the drug naive ADHD group after a washout period after 1 year of continuous administration (Part A, Part D). 6) The relationship between changes in frontal lobe functions and genetic polymorphisms (Part A, Part B, Part C, Part D). | — |
Countries
Japan
Contacts
Public ContactAyaka Ishii-Takahashi
University of Tokyo The department of Psychiatry
Outcome results
None listed