UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029915
Receipt number R000034173
Scientific Title Individual change factors for placebo reaction:Study of placebome and personality trait
Date of disclosure of the study information 2017/11/30
Last modified on 2021/05/13 14:02:05

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Basic information

Public title

Individual change factors for placebo reaction:Study of placebome and personality trait

Acronym

Individual change factors for placebo reaction

Scientific Title

Individual change factors for placebo reaction:Study of placebome and personality trait

Scientific Title:Acronym

Individual change factors for placebo reaction

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Study of genetic polymorphism and personality trait for placebo reaction

Basic objectives2

Others

Basic objectives -Others

effect of placebo

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

subjective indicator:Stanford sleepiness scale(SSS),Visual analogue scale
objective indicator:serotonin transporter polymorphic, catechol-o-transferase transporter polymorphic

Key secondary outcomes

subjective indicator:Stanford sleepiness ssubjective indicator Personality examination
objective indicator:blood flow of Brain prefrontal area


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

placebo administration(lactose), single dose

Interventions/Control_2

placebo administration(lactose), single dose

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

Healthy subjects

Key exclusion criteria

intreatment, subjects with allergy for drugs and foods

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Thoru
Middle name
Last name Aomori

Organization

Faculty of pharmacy, Keio university

Division name

Division of Hospital Pharmacy Science

Zip code

105-8512

Address

1-5-30, Shibakoen, Minato-ku, Tokyo, Japan

TEL

03-5400-2796

Email

Mochizuki-my@pha.keio.ac.jp


Public contact

Name of contact person

1st name Minae
Middle name
Last name Isawa

Organization

Faculty of pharmacy, Keio university

Division name

Division of Hospital Pharmacy Science

Zip code

105-8512

Address

1-5-30, Shibakoen, Minato-ku, Tokyo, Japan

TEL

03-5400-2796

Homepage URL


Email

isawa-mn@pha.keio.ac.jp


Sponsor or person

Institute

Keio university hospital
Department of Neuropsychiatry, Keio University school of Medicine

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for scientific Research

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University Clinical Center

Address

35 shinano-machi shinjyuku-ku Tokyo

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp


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

慶應義塾大学付属病院


Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 30 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000034173

Publication of results

Unpublished


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000034173

Number of participants that the trial has enrolled

120

Results

Confirmation of the existence of a placebo effect: Both SSS and VAS, a measure of sleepiness, improved significantly after placebo administration (P < 0.001), confirming the placebo effect. Workload increased significantly (P < 0.001) after taking placebo.

Results date posted

2021 Year 05 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy Volunteers

Participant flow

complete

Adverse events

no

Outcome measures

placebo effect

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 10 Month 15 Day

Date of IRB

2017 Year 10 Month 15 Day

Anticipated trial start date

2018 Year 01 Month 20 Day

Last follow-up date

2020 Year 01 Month 31 Day

Date of closure to data entry

2020 Year 02 Month 27 Day

Date trial data considered complete

2020 Year 02 Month 27 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 11 Month 10 Day

Last modified on

2021 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034173


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name