UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008460 |
|---|---|
| Receipt number | R000009952 |
| Scientific Title | fMRI study with OROS-methylphenidate treatment in pediatric ADHD |
| Date of disclosure of the study information | 2012/08/08 |
| Last modified on | 2020/07/22 14:32:06 |
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Basic information
Public title
fMRI study with OROS-methylphenidate treatment in pediatric ADHD
Acronym
fMRI study in ADHD with OROS-methylphenidate
Scientific Title
fMRI study with OROS-methylphenidate treatment in pediatric ADHD
Scientific Title:Acronym
fMRI study in ADHD with OROS-methylphenidate
Region
| Japan |
Condition
Condition
ADHD
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate brain activation with functional magnetic resonance imaging during a reward sensitivity paradigm that consists of high monetary reward and low monetary reward conditions before and after a 3-month treatment with osmotic release oral system-methylphenidate.
Basic objectives2
Others
Basic objectives -Others
efficacy and brain function
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain function before and after a 3-month treatment with osmotic release oral system-methylphenidate
Key secondary outcomes
ADHD-RS score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Gene |
Interventions/Control_1
Patient group
3 months
1mg/kg
daily
Interventions/Control_2
Control group
No treatment
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
| 9 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male
Key inclusion criteria
Children and adolescents with ADHD who met the Diagnostic and Statistical Manual of Mental Disorders DSM-IV Text Revision (DSM-IV-TR) criteria.
Healthy children and adolescents with higher level of IQ 80.
Key exclusion criteria
Participants were excluded who had any history of substance abuse, recent substance use, head trauma with loss of consciousness, epilepsy, significant fetal exposure to alcohol or drugs, perinatal or neonatal complications, neurological disorders, or medical conditions that could adversely affect growth and development.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Tomoda |
Organization
University of Fukui
Division name
Research Center for Child Mental Development, Graduate School of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho Fukui, 910-1193 Japan
TEL
0776-61-8691
atomoda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Tomoda |
Organization
University of Fukui
Division name
Research Center for Child Mental Development, Graduate School of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho Fukui, 910-1193 Japan
TEL
0776-61-8691
Homepage URL
http://www.med.u-fukui.ac.jp/cdrc/welcome.html
atomoda@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (Houga) from the Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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 Matsuoka-Shimoaizuki, Eiheiji-cho 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
福井大学病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/24179790
Publication of results
Partially published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24179790
Number of participants that the trial has enrolled
Results
Attention-deficit/hyperactivity disorder (ADHD) is neurobehavioral disorder characterized by inattention, hyperactivity/impulsivity and impaired reward system function, such as delay aversion and low reward sensitivity. The pharmacological treatment for ADHD includes methylphenidate (MPH), or osmotic release oral system-MPH (OROS-MPH), which increases extrasynaptic dopamine and noradrenaline levels by blocking their reuptake. Although previous functional magnetic resonance imaging (fMRI) studies revealed that acute treatment with MPH alters activation of the nucleus accumbens during delay aversion in children and adolescents with ADHD, the effects a relatively long period of OROS-MPH treatment on delay aversion as well as reward sensitivity remain unclear. Thus, we evaluated brain activation with fMRI during a reward sensitivity paradigm that consists of high monetary reward and low monetary reward conditions before and after a 3-month treatment with OROS-MPH in 17 children and adolescents with ADHD (mean age, 13.3) and 17 age- and sex-matched healthy controls (mean age, 13.0). We found that before treatment there was decreased activation of the nucleus accumbens and thalamus in patients with ADHD during only the low monetary reward condition, which was improved to same level as those of the healthy controls after the treatment. The observed change in brain activity was associated with improved ADHD symptom scores, which were derived from Japanese versions of the ADHD rating scale. These results suggest that treatment with OROS-MPH for a relatively long period is effective in controlling reward sensitivity in children and adolescents with ADHD.
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
| 2009 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 17 | Day |
Last modified on
| 2020 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009952
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