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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008232
Receipt No. R000009703
Scientific Title Effect of mazindol on dopamine transporter
Date of disclosure of the study information 2012/07/01
Last modified on 2016/08/10

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Basic information
Public title Effect of mazindol on dopamine transporter
Acronym Effect of mazindol on DAT
Scientific Title Effect of mazindol on dopamine transporter
Scientific Title:Acronym Effect of mazindol on DAT
Region
Japan

Condition
Condition Healthy male subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of clinical dose of mazindol on dopamine transporter
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Binding of clinical dose of mazindol to dopamine transporter
Key secondary outcomes 1. Effect of clinical dose of mazindol on dopamine release
2. Effect of clinical dose of mazindol on cerebral blood flow and cognitive functions

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 1.5 mg of mazindol p.o.
Interventions/Control_2 [C-11]raclopride PET and [F-18]FE-PE2I PET
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 16

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, Chiba 263-8555, Japan
TEL 043-206-3251
Email y-kimura@nirs.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuko Suzuki
Organization National Institute of Radiological Sciences
Division name clinical research support unit
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba, Chiba 263-8555, Japan
TEL 043-206-3251
Homepage URL
Email volunteer@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 Self funding
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

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 01 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
2012 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 07 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
2012 Year 06 Month 22 Day
Last modified on
2016 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009703

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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