UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026723 |
|---|---|
| Receipt number | R000030680 |
| Scientific Title | Dopamine D1 receptor and noradrenaline transporter in neurodevelopmental disorders |
| Date of disclosure of the study information | 2017/03/28 |
| Last modified on | 2021/05/19 19:28:10 |
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Basic information
Public title
Dopamine D1 receptor and noradrenaline transporter in neurodevelopmental disorders
Acronym
Dopamine and noradrenaline neurotransmitter in neurodevelopmental disorders
Scientific Title
Dopamine D1 receptor and noradrenaline transporter in neurodevelopmental disorders
Scientific Title:Acronym
Dopamine and noradrenaline neurotransmitter in neurodevelopmental disorders
Region
| Japan |
Condition
Condition
neurodevelopmental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate associations between symptoms in neurodevelopmental disorders and availability of dopamine D1 receptor and noradrenaline transporter in the brain
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Availability of dopamine D1 receptor and noradrenaline transporter in the brain
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
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who can understand the content of this study. Each patient must meet the diagnostic criterion.
Key exclusion criteria
Subjects with severe physical, or other psychiatric diseases
Subjects with strong suicide ideation
Subjects during (probable) pregnancy or breast-feeding
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 Research National Institute of Radiological Sciences
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
+81-43-206-3251
kubota.manabu@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
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
+81-43-206-3251
Homepage URL
suzuki.kazuko@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Institute of Developmental Disabilities Research, Showa University Karasuyama Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of National Institutes for Quantum and Radiological Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba
Tel
043-206-4709
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
| 2017 | Year | 03 | Month | 28 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 27 | Day |
Last modified on
| 2021 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030680
