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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011428
Receipt No. 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

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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
Email 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
Email helsinki@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013379

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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