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

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

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

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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name