UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011428 |
|---|---|
| Receipt number | R000013379 |
| Scientific Title | Effect of antipsychotic risperidone on presynaptic dopaminergic function |
| Date of disclosure of the study information | 2013/08/08 |
| Last modified on | 2014/08/08 13:40:28 |
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Basic information
Public title
Effect of antipsychotic risperidone on presynaptic dopaminergic function
Acronym
Effect of antipsychotic risperidone on presynaptic dopaminergic function
Scientific Title
Effect of antipsychotic risperidone on presynaptic dopaminergic function
Scientific Title:Acronym
Effect of antipsychotic risperidone on presynaptic dopaminergic function
Region
| Japan |
Condition
Condition
Healthy male volunteer
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to measure change in dopamine transporter availability by an antipsychotic, risperidone, by using positron emission tomography (PET) with [18F]FE-PE2I in healthy subjects. PET scans will be performed twice after single dose of risperidone. We will also perform magnetic resonance imaging (MRI) and psychological tests on the same day the PET scans are performed.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in dopamine transporter availability by single dose of risperidone and its relevance to performance in psychological test as well as brain functions measured by MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
risperidone 2.0 mg p.o
Interventions/Control_2
placebo p.o
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 volunteers who do not have any psychiatric disorders or serious medical illnesses and who are able to understand an explanatory document and give consent are included in this study
Key exclusion criteria
-Psychiatric disorders including drug dependence
-Serious medical illness
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kimura |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3251
y-kimura@nirs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Tamoyama |
Organization
National Institute of Radiological Sciences
Division name
A study ethic plan support room
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3193
Homepage URL
helsinki@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 08 | Day |
Last modified on
| 2014 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013379
