| 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) |
| 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 | |
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| Condition | ||
| Condition | ADHD | |
| Classification by specialty |
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| 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 |
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| Interventions/Control_1 | Patient group
3 months 1mg/kg daily |
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| Interventions/Control_2 | Control group
No treatment |
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| Eligibility | ||||
| Age-lower limit |
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| 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. |
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| 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 | |||
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| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 |
| 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) |
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| Date of disclosure of the study information |
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| 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. |
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| Recruitment status | Completed | ||||||
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009952 |