UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009741
Receipt number R000011418
Scientific Title Imaging study of using positron emission tomography to compare the the effect of SSRI on serotonin transporter
Date of disclosure of the study information 2013/02/01
Last modified on 2019/12/19 17:28:26

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Basic information

Public title

Imaging study of using positron emission tomography to compare the the effect of SSRI on serotonin transporter

Acronym

Comparative study of the effect of SSRI on serotonin transporter

Scientific Title

Imaging study of using positron emission tomography to compare the the effect of SSRI on serotonin transporter

Scientific Title:Acronym

Comparative study of the effect of SSRI on serotonin transporter

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the clinical usefulness and characteristics of SSRIs. To evaluate the serotonin transporter binding potential and its time-dependent change.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

serotonin transporter binding potential

Key secondary outcomes

blood concentration, MRI, hepatic metabolizing enzyme


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

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, hepatic metabolizing enzyme

Interventions/Control_2

PET, MRI, blood concentration, hepatic metabolizing enzyme

Interventions/Control_3

PET, MRI, blood concentration, hepatic metabolizing enzyme

Interventions/Control_4

PET, MRI, blood concentration, hepatic metabolizing enzyme

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
- taking drug which has interaction with SSRI
- subject who are judged as not suitable for participation in this study

Target sample size

16


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 or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

None

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

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

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

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

2015 Year 01 Month 31 Day

Date of closure to data entry

2015 Year 02 Month 28 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2015 Year 03 Month 31 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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011418


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name