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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022301
Receipt No. R000025638
Scientific Title Observational study of placebo effect for a variable factor between individuals-reactive character mediated serotonin transporter genotype
Date of disclosure of the study information 2017/08/31
Last modified on 2016/05/13

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Basic information
Public title Observational study of placebo effect for a variable factor between individuals-reactive character mediated serotonin transporter genotype
Acronym placebo effect for a variable factor between individuals
Scientific Title Observational study of placebo effect for a variable factor between individuals-reactive character mediated serotonin transporter genotype
Scientific Title:Acronym placebo effect for a variable factor between individuals
Region
Japan

Condition
Condition Hearthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Observational study of placebo effect for a variable factor between individuals - reactive character mediated serotonin transporter genotyp
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Finding of responders and non-responders for placebo effect by gene polymorphism of serotonine trasporter
Key secondary outcomes Finding of cognitive indicator of placebo reaction by brain prefrontal cortex activity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 placebo drug (lactose)
Interventions/Control_2 caffine
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
35 years-old >
Gender Male and Female
Key inclusion criteria Participants who Candidates received a doctor's examination and physical examination(height, weight, temperature, and blood pressure)
Key exclusion criteria Participants are selected by doctor
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Emi Nakashima
Organization Faculty of Pharmacy, Keio University
Division name Division of Pharmaceutics
Zip code
Address 1-5-30, Shibako-en, Minato-ku, Tokyo
TEL 03-5400-2660
Email nakashima-em@pha.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minae Isawa
Organization Faculty of Pharmacy, Keio University
Division name Division of Pharmaceutics
Zip code
Address 1-5-30, Shibako-en, Minato-ku, Tokyo
TEL 03-5400-2660
Homepage URL
Email isawa-mn@pha.keio.ac.jp

Sponsor
Institute Faculty of Pharmacy, Keio University
Division of Pharmaceutics
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 08 Month 31 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
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 04 Month 01 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 05 Month 13 Day
Last modified on
2016 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025638

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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