UMIN-CTR Clinical Trial

Public title

The exploratory study about the neurophysiological index which predicts the effect of the methylphenidate hydrochloride in children with AD/HD

Acronym

The exploratory study about the neurophysiological index which predicts the effect of the methylphenidate hydrochloride in children with AD/HD

Scientific Title

The exploratory study about the neurophysiological index which predicts the effect of the methylphenidate hydrochloride in children with AD/HD

Scientific Title:Acronym

The exploratory study about the neurophysiological index which predicts the effect of the methylphenidate hydrochloride in children with AD/HD

Region

Japan

Condition

Attention deficit hyperactivity disorder

Classification by specialty

Pediatrics

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to develop a neurophysiological index, which predicts a medicinal effect of MPH before starting continuous medication to children with AD/HD.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

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).

Key secondary outcomes

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).

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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)

Interventions/Control_2

placebo (one day)=> washout (1week) => MPH (one day) => MPH (4-8-weeks)
=> 1-y continuous administration of MPH
(drug naive ADHD group)(as an ancillary study)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

6

years-old

<=

Age-upper limit

13

years-old

>

Gender

Male and Female

Key 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.

Key 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.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yukiko Kano

Organization

The University of Tokyo

Division name

Child Neuropsychiatry

Zip code

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

Name of contact person

1st name
Middle name
Last name	Ayaka Ishii-Takahashi

Organization

University of Tokyo

Division name

The department of Psychiatry

Zip code

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL

Email

ayayak-tky@umin.co.jp

Institute

University of Tokyo Medical School
The department of Psychiatry

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare.Health and Labour Sciences Research Grants.Research on Psychiatric and Neurological Diseases and Mental Health.(H17-kokoro-004)

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

P2007009

Org. issuing International ID_1

clinical research center University of Tokyo Hospital

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2008

Year

07

Month

24

Day

Date of IRB

Anticipated trial start date

2008

Year

08

Month

01

Day

Last follow-up date

2011

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

07

Month

28

Day

Last modified on

2012

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001546