UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038895 |
|---|---|
| Receipt number | R000044351 |
| Scientific Title | Associations between changes in dopamine and noradrenaline transporters and clinical symptoms in patients with ADHD taking methylphenidate |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2023/12/18 19:07:08 |
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Basic information
Public title
Associations between changes in dopamine and noradrenaline transporters and clinical symptoms in patients with ADHD taking methylphenidate
Acronym
Associations between changes in dopamine and noradrenaline transporters and clinical symptoms in patients with ADHD taking methylphenidate
Scientific Title
Associations between changes in dopamine and noradrenaline transporters and clinical symptoms in patients with ADHD taking methylphenidate
Scientific Title:Acronym
Associations between changes in dopamine and noradrenaline transporters and clinical symptoms in patients with ADHD taking methylphenidate
Region
| Japan |
Condition
Condition
ADHD
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify molecular mechanism that causes changes in clinical symptoms in patients with ADHD
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Associations between binding changes in dopamine and noradrenaline transporters and symptom changes by conducting two sets of PET scans (with and without taking methylphenidate)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
healthy controls
Interventions/Control_2
patients with ADHD
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who can understand the content of this study. Each patient must meet the diagnostic criterion. Only patients being prescribed methylphenidate for a clinical reason can be included.
Key exclusion criteria
Subjects with severe physical, or other psychiatric diseases
Subjects with strong suicidal ideation
Subjects during (probable) pregnancy or breast-feeding
Subjects who were judged not suitable for other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kiwamu |
| Middle name | |
| Last name | Matsuoka |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Functional Brain Imaging National Institute of Radiological Sciences
Zip code
263-0043
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
+81-43-206-3251
matsuoka.kiwamu@qst.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Suzuki |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Clinical Research Section
Zip code
263-0043
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
+81-43-206-3251
Homepage URL
suzuki.kazuko@qst.go.jp
Sponsor or person
Institute
Department of Functional Brain Imaging
National Institute of Radiological Sciences
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Borad National Institutes for Quantum and Radiological Sciences and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba
Tel
+81-43-206-4706
helsinki@qst.go.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | 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
| 2019 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2019 | Year | 12 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044351
