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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001270
Receipt No. R000001546
Scientific Title The exploratory study about the neurophysiological index which predicts the effect of the methylphenidate hydrochloride in children with AD/HD
Date of disclosure of the study information 2008/08/01
Last modified on 2012/11/30

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Basic information
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
Condition Attention deficit hyperactivity disorder
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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).


Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute University of Tokyo Medical School
The department of Psychiatry
Institute
Department

Funding Source
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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
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
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2008 Year 07 Month 28 Day
Last modified on
2012 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001546

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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