UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006962 |
|---|---|
| Receipt number | R000008221 |
| Scientific Title | Objective evaluation for changes of dopamine transporter using PET with [18F]FE-PE2I among psychiatric illnesses. |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2018/07/02 10:37:14 |
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Basic information
Public title
Objective evaluation for changes of dopamine transporter using PET with [18F]FE-PE2I among psychiatric illnesses.
Acronym
Evaluation for dopamine transporter using PET with [18F] FE-PE2I among psychiatric illnesses.
Scientific Title
Objective evaluation for changes of dopamine transporter using PET with [18F]FE-PE2I among psychiatric illnesses.
Scientific Title:Acronym
Evaluation for dopamine transporter using PET with [18F] FE-PE2I among psychiatric illnesses.
Region
| Japan |
Condition
Condition
healthy adults, dementia with lewy body (DLB), schizophrenia, mood disorder, REM sleep behavior disorder (RBD), Attention deficit hyperactivity disorder (ADHD)
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the functional changes of dopamin transporter among DLB, Schizophrenia, mood disorder, RBD, ADHD, and healthy adults by PET with [18F] FE-PE2I
Basic objectives2
Others
Basic objectives -Others
To characterize the differences among DLB, Schizophrenia, mood disroder, RBD, ADHD, and healthy adults.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative measurement of brain dopamine transporter binding
Key secondary outcomes
brain MRI
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
6
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
PET, MRI, neuropsychological batteries, neurological examinations
Interventions/Control_2
PET, MRI, neuropsychological batteries, neurological examinations
Interventions/Control_3
PET, MRI, neuropsychological batteries, neurological examinations
Interventions/Control_4
PET, MRI, neuropsychological batteries, neurological examinations
Interventions/Control_5
PET, MRI, neuropsychological batteries, neurological examinations
Interventions/Control_6
PET, MRI, neuropsychological batteries, neurological examinations
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults
- without past or current history of psychiatric illnesses
illnesses groups
- who met the diagnostic criteria of DLB, Schizophrenia, Mood disorder, RBD, or ADHD
Key exclusion criteria
Exclusion criteria:
- With past or current history of serious medical illness and/or brain organic diseases
- Subject who is contraindicated for the use of MRI
- With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- Subjects who are judged as not suitable for participation in this study
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiro Okubo, M.D., Ph.D. |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
okubo-y@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Amane Tateno, M.D., Ph.D. |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
Homepage URL
amtateno@nms.a.cjp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本医科大学付属病院健診医療センター、日本医科大学付属病院、メディカルサテライト八重洲クリニック
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 27 | Day |
Last modified on
| 2018 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008221
| Research Plan | |
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