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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004357 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | healthy male adults | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 15 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Results | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Other | |
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Management information | |||||||
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Last modified on |
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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 |