UMIN-CTR Clinical Trial

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
Institute	Molecular Imaging Center, National Institute of Radiological Sciences
Institute
Department

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
URL(English)	https://upload.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

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