UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000008460
Receipt No. 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 (Ver. 10)

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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
Email 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
Email atomoda@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009952