UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027533 |
|---|---|
| Receipt number | 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 | 2020/11/30 10:37:22 |
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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
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Tomoda |
Organization
University of Fukui, Research Center for Child Mental Development
Division name
Division of Psychosocial Support for Nurturing
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, 910-1193, Japan
TEL
0776-61-8677
atomoda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Tomoda |
| Middle name | |
| Last name | Akemi |
Organization
University of Fukui, Research Center for Child Mental Development
Division name
Division of Psychosocial Support for Nurturing
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, 910-1193, Japan
TEL
0776-61-8677
Homepage URL
atomoda@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui, Research Center for Child Mental Development, Division of Psychosocial Support for Nurturing
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of the University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, 910-1193, Japan
Tel
0776-61-3111
watanabe@u-fukui.ac.jp
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
34
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
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
| 2020 | 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=R000031550
