UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004357
Receipt number R000004981
Scientific Title Regional difference in dopamine D2 receptor occupancy by aripiprazole in humans: a positron emission tomography study.
Date of disclosure of the study information 2010/10/12
Last modified on 2011/09/07 18:13:05

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Basic information

Public title

Regional difference in dopamine D2 receptor occupancy by aripiprazole in humans: a positron emission tomography study.

Acronym

Regional difference in dopamine D2 receptor occupancy by aripiprazole in humans: a positron emission tomography study.

Scientific Title

Regional difference in dopamine D2 receptor occupancy by aripiprazole in humans: a positron emission tomography study.

Scientific Title:Acronym

Regional difference in dopamine D2 receptor occupancy by aripiprazole in humans: a positron emission tomography study.

Region

Japan


Condition

Condition

healthy male adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the regional difference of D2 receptor occupancy by aripiprazole using positron emission tomography in healthy male adults

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Regional difference of D2 receptor occupancy by aripiprazole using [11C]raclopride and [11C]FLB457.

Key secondary outcomes



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

Injection of [11C]racropride and [11C]FLB457 intravenously for PET scan before and after administration of aripirazole. The dosage of aripiprazole is 6mg.

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

40 years-old >

Gender

Male

Key inclusion criteria

Healthy male subjects who have the ability to provide informed consent

Key exclusion criteria

-Psychiatric disorders including drug dependence
-Serious medical illness

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Ito

Organization

National Institute of Radiological Sciences

Division name

Clinical Neuroimaging Team, Molecular Neuroimaging Group, Molecular Imaging Center

Zip code


Address

4-9-1 Anagawa, Inage-ku, Chiba 263-8555, JAPAN

TEL

043-206-3251

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

National Institute of Radiological Sciences

Division name

Clinical Neuroimaging Team, Molecular Neuroimaging Group, Molecular Imaging Center

Zip code


Address

4-9-1 Anagawa, Inage-ku, Chiba 263-8555, JAPAN

TEL

043-206-3251

Homepage URL


Email



Sponsor or person

Institute

Molecular Imaging Center, National Institute of Radiological Sciences

Institute

Department

Personal name



Funding Source

Organization

National Institute of Radiological Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

独立行政法人 放射線医学総合研究所
National Institute of Radiological Sciences


Other administrative information

Date of disclosure of the study information

2010 Year 10 Month 12 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

2010 Year 06 Month 14 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2011 Year 07 Month 01 Day

Date of closure to data entry

2011 Year 07 Month 01 Day

Date trial data considered complete

2011 Year 07 Month 01 Day

Date analysis concluded

2011 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 10 Month 07 Day

Last modified on

2011 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004981


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name