UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019300
Receipt number R000022241
Scientific Title Study of the effect of psychotrophics on cognitive function and driving performance including gene and fMRI analysis
Date of disclosure of the study information 2015/10/09
Last modified on 2022/10/14 09:25:56

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Basic information

Public title

Study of the effect of psychotrophics on cognitive function and driving performance including gene and fMRI analysis

Acronym

Study of the effect of psychotrophics on cognitive function and driving performance including gene and fMRI analysis

Scientific Title

Study of the effect of psychotrophics on cognitive function and driving performance including gene and fMRI analysis

Scientific Title:Acronym

Study of the effect of psychotrophics on cognitive function and driving performance including gene and fMRI analysis

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The objectives is to elucidate the effect of psychotropics on driving performance, cognitive function, neural basis of central nervous system, and stress responsiveness.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Driving performance by driving simulator

Key secondary outcomes

Cognitive performance (attention, executive function, memory), equibalent function, Stanford sleepiness scale, fMRI, gene polymorphism, and stress related substance


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Zopiclone 7.5 mg single dose

Interventions/Control_2

Placebo

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

65 years-old >

Gender

Male

Key inclusion criteria

Healthy adult men who have a driving license and from whom written informed consent was obtained

Key exclusion criteria

Female, patients with physical and psychiatric disorders, under 20 years old and over 55 years old

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Norio
Middle name
Last name Ozaki

Organization

Nagoya University Graduate School of Medicine

Division name

Pathophysiology of Mental Disorders

Zip code

466-8550

Address

Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan

TEL

+81527442282

Email

ozaki-n@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Kunihiro
Middle name
Last name Iwamoto

Organization

Nagoya University Graduate School of Medicine

Division name

Psychiatry

Zip code

466-8550

Address

Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan

TEL

+81527442282

Homepage URL


Email

iwamoto@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

Nagoya University Graduate School of Medicine and Nagoya University Hospital ethics review committee

Address

Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan

Tel

052-744-2479

Email

ethics@med.nagoya-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

1747CP-4

Org. issuing International ID_1

Hakata Clinic Institutional Review Board

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

医療法人相生会(福岡県)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 09 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

28

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

No longer recruiting

Date of protocol fixation

2005 Year 05 Month 30 Day

Date of IRB

2010 Year 06 Month 28 Day

Anticipated trial start date

2018 Year 06 Month 27 Day

Last follow-up date

2025 Year 06 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We recruit healthy perticipants without history of psychiatric disorders who do not take psychotrophics


Management information

Registered date

2015 Year 10 Month 09 Day

Last modified on

2022 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022241


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name