UMIN-CTR Clinical Trial

Basic information
Public title	Imaging study of using positron emission tomography for the effect of nootropics (tramadol) on the athletic performance
Acronym	PET imaging for the effect of tramadol
Scientific Title	Imaging study of using positron emission tomography for the effect of nootropics (tramadol) on the athletic performance
Scientific Title:Acronym	PET imaging for the effect of tramadol
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 serotonin 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	To investigate the effect of the nootropics on the serotonin transporter quantified by positron emission tomography
Key secondary outcomes	blod 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	2
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
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	Subjects who have the ability to provide informed consent and adhere to the protocol.
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	10

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
Email	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
Email	amtateno@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

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	+81-3-3822-2131
Email	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	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、八重洲クリニック

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

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	2012 Year 12 Month 27 Day
Date of IRB	2013 Year 01 Month 25 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date	2013 Year 12 Month 31 Day
Date of closure to data entry	2013 Year 12 Month 31 Day
Date trial data considered complete	2014 Year 01 Month 01 Day
Date analysis concluded	2014 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date	2013 Year 01 Month 10 Day
Last modified on	2019 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011424