UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015546
Receipt number R000018065
Scientific Title Seronergic transporter function in normal volunteers: correlation with age and regional cerebral glucose metabolism.
Date of disclosure of the study information 2014/11/30
Last modified on 2023/10/24 09:38:36

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Basic information

Public title

Seronergic transporter function in normal volunteers: correlation with age and regional cerebral glucose metabolism.

Acronym

Correlation of serotonergic function with age and regional cerebral glucose metabolism.

Scientific Title

Seronergic transporter function in normal volunteers: correlation with age and regional cerebral glucose metabolism.

Scientific Title:Acronym

Correlation of serotonergic function with age and regional cerebral glucose metabolism.

Region

Japan


Condition

Condition

Healthy normal volunteers

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of age-related effect on regional cerebral glucose metabolism and sertonergic transporter function.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Regional cerebral serotonergic transporter binding potential.

Key secondary outcomes

Correlation of serotonergic transporter binding potential and regional cerebral glucose metabolism.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

normal volunteer

Interventions/Control_2


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

70 years-old >

Gender

Male

Key inclusion criteria

Volunteer presenting with written informed consent.

No contraindication for standard medical check-up including PET/CT, MR imaging and neuropsychological tests.

Key exclusion criteria

Incapable with imaging or neuropsychological tests.

Under psychiatric medical therapy.

Under medical/non-medical treatment for chronic disorder.

Abnormal physical status including obesity.

No past history of severe mental stress.

Currently presenting with depressive symptoms.

Addiction with any recreational drugs including nicotine.

Sleep disorder.

Past history of traumatic brain injury.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoya Hattori

Organization

Hokkaido University

Division name

Imaging

Zip code


Address

Hokkaido

TEL

011-706-5152

Email

nhattori@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoya Hattori

Organization

Hokkaido University

Division name

Imaging

Zip code


Address

Hokkaido

TEL

011-706-5152

Homepage URL


Email

nhattori@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido

Institute

Department

Personal name



Funding Source

Organization

Hokkaido

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



Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 30 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

2015 Year 01 Month 06 Day

Date of IRB

2015 Year 01 Month 06 Day

Anticipated trial start date

2015 Year 01 Month 06 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 28 Day

Last modified on

2023 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018065


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name