UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of placebo effect for a variable factor between individuals-reactive character mediated serotonin transporter genotype
Title of the study (Brief title)	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

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Emi Nakashima
Organization	Faculty of Pharmacy, Keio University
Division name	Division of Pharmaceutics
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	Minae Isawa
Organization	Faculty of Pharmacy, Keio University
Division name	Division of Pharmaceutics
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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