UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033337
Receipt number R000038006
Scientific Title Sensory processing patients with Mental illness
Date of disclosure of the study information 2018/07/09
Last modified on 2020/01/09 14:31:36

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Basic information

Public title

Sensory processing patients with Mental illness

Acronym

Sensory processing patients with Mental illness

Scientific Title

Sensory processing patients with Mental illness

Scientific Title:Acronym

Sensory processing patients with Mental illness

Region

Japan


Condition

Condition

Mental illness

Classification by specialty

Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate sensory processing comparing healthy control to patients with mental illness.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reaction potential, latency and suppression rate for each mental illness

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Those aged 20 years or older who are not asked about gender, who can obtain consent by explanation document.

Key exclusion criteria

Those whose research participants judged inappropriate for participation in this survey.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Nishihara

Organization

Aichi medical university

Division name

Multidisciplinary Pain Center

Zip code

480-1195

Address

aichi prefecture yazako karimata

TEL

0561-62-3311

Email

ck410621@gmail.com


Public contact

Name of contact person

1st name Nobuyuki
Middle name
Last name Takeuchi

Organization

Aichi medical university

Division name

Department of Psychiatry

Zip code

480-1195

Address

aichi prefecture yazako karimata

TEL

0561-62-3311

Homepage URL


Email

jamjam053@yahoo.co.jp


Sponsor or person

Institute

Aichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

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

Aichi medical university

Address

Aichi prefecture Yazako city 1-1

Tel

0561-62-3311

Email

amu_ethics@aichi-med-u.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



Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 09 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

Preinitiation

Date of protocol fixation

2018 Year 09 Month 03 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 03 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Not particularly


Management information

Registered date

2018 Year 07 Month 09 Day

Last modified on

2020 Year 01 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038006


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name