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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006962
Receipt No. 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

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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
Email 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
Email amtateno@nms.a.cjp

Sponsor
Institute Nippon Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008221

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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