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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027533
Receipt No. R000031550
Scientific Title A research for the effect of the treatment in children with attention-deficit/hyperactivity disorder using resting state functional magnetic resonance imaging.
Date of disclosure of the study information 2017/06/01
Last modified on 2018/01/24

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Basic information
Public title A research for the effect of the treatment in children with attention-deficit/hyperactivity disorder using resting state functional magnetic resonance imaging.
Acronym A rs-fMRI study for the effect of the treatment in ADHD
Scientific Title A research for the effect of the treatment in children with attention-deficit/hyperactivity disorder using resting state functional magnetic resonance imaging.
Scientific Title:Acronym A rs-fMRI study for the effect of the treatment in ADHD
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect of methylphenidate in children with ADHD using resting state fMRI
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Resting state fMRI analysis: Comparison of brain function after methylphenidate or placebo administration.
Key secondary outcomes Neuropsychological test

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Single administration of methylphenidate
Interventions/Control_2 Single administration of placebo
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
17 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with attention-deficit/hyperactivity disorder based on the classifications in the diagnostic and statistical manual of mental disorders (DSM-5).
2) Subjects within the age range of 6-17 years old.
3) Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
Key exclusion criteria 1) History of allergy for methylphenidate.
2) Subjects who have any other current DSM-5 diagnosis of the following;
"schizophrenia", "substance-related disorders", "eating disorders", "personality disorders".
3) Subjects who have a physical disorder with a need of strict diet, or a diagnosis of a severe physical disorder.
4) Women who are breastfeeding, pregnant, possibility of pregnancy, or have a wish of early pregnancy.
5) Subjects with metalic device in their body.
6) Subjects who, in the Investigator's opinion, might not be suitable for the study.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Akemi Tomoda
Organization University of Fukui, Research Center for Child Mental Development
Division name Division of Psychosocial Support for Nurturing
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, 910-1193, Japan
TEL 0776-61-8677
Email atomoda@u-fukui.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Akemi Tomoda
Organization University of Fukui, Research Center for Child Mental Development
Division name Division of Psychosocial Support for Nurturing
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, 910-1193, Japan
TEL 0776-61-8677
Homepage URL
Email atomoda@u-fukui.ac.jp

Sponsor
Institute University of Fukui, Research Center for Child Mental Development, Division of Psychosocial Support for Nurturing
Institute
Department

Funding Source
Organization Japan Society for the promotion of science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 福井大学医学部附属病院(福井県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 29 Day
Last modified on
2018 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031550

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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