UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020150 |
|---|---|
| Receipt number | R000023272 |
| Scientific Title | Imaging study of using positron emission tomography for the effect of nootropics (atomoxetine, sertraline, paroxetine, benztropine) on the athletic performance |
| Date of disclosure of the study information | 2015/12/11 |
| Last modified on | 2020/12/14 08:58:52 |
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Basic information
Public title
Imaging study of using positron emission tomography for the effect of nootropics (atomoxetine, sertraline, paroxetine, benztropine) on the athletic performance
Acronym
PET imaging for the effect of atomoxetine, sertraline, paroxetine, and benztropine
Scientific Title
Imaging study of using positron emission tomography for the effect of nootropics (atomoxetine, sertraline, paroxetine, benztropine) on the athletic performance
Scientific Title:Acronym
PET imaging for the effect of atomoxetine, sertraline, paroxetine, and benztropine
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of nootropics on the monoaminergic neuron system (dopamine transporter) using positron emission tomography. To evaluate the association between imaging data and blood and/or urine concentration.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of the nootropics on the monoaminergic neuron system (dopamine transporter).
Key secondary outcomes
blood and/or urine concentration, 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
4
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
PET, MRI, blood concentration, urine concentration
Interventions/Control_2
PET, MRI, blood concentration, urine concentration
Interventions/Control_3
PET, MRI, blood concentration, urine concentration
Interventions/Control_4
PET, MRI, blood concentration, urine concentration
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Subjects who have the ability to provide informed consent and adhere to the protocol.
Subjects without the history of smoking.
Key exclusion criteria
Exclusion criteria:
- with past or current history of psychiatric illness
- 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 ofsevere liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- subject who are judged as not suitable for participation in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Okubo |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
+81-3-3822-2131
okubo-y@nms.ac.jp
Public contact
Name of contact person
| 1st name | Amane |
| Middle name | |
| Last name | Tateno |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
+81-3-3822-2131
Homepage URL
amtatneo@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Nippon Medical School Hospital Institutional Review Board
Address
1-1-5, Sendagi, Bunkyo-Ku, Tokyo, Japan
Tel
03-3822-2131
clinicaltrial@nms.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Partially published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
20
Results
average dopamine transporter occupancy
caudate putamen
sertraline 25mg 4.8% 6.5%
paroxetine 10mg 3.5% 2.9%
atomoxetine 40mg 1.3% 1.1%
benztropine 0.5mg -4.7% -6.4%
Results date posted
| 2020 | Year | 12 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy subjects
Participant flow
1. apply
2. eligibility evaluation, informed consent
3. participation in examination
4. check for adverse events
Adverse events
none
Outcome measures
occupancy of dopamine transporter
drug blood concentration
drug urinary concentration
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023272
