UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019167
Receipt number R000022162
Scientific Title Functional and structural MRI study of mental disorders"
Date of disclosure of the study information 2015/09/30
Last modified on 2022/04/13 10:35:56

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Basic information

Public title

Functional and structural MRI study of mental disorders"

Acronym

MRI study

Scientific Title

Functional and structural MRI study of mental disorders"

Scientific Title:Acronym

MRI study

Region

Japan


Condition

Condition

Schizophrenia
Mood disorder
Autism
Demrntia

Classification by specialty

Psychiatry Adult Child

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Investigate relathinship between mental disorders and brain structure/function

Basic objectives2

Others

Basic objectives -Others

Neuronal correlates of mental disorders

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Brain structure and function as measured by MRI

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

6 years-old <=

Age-upper limit

95 years-old >=

Gender

Male and Female

Key inclusion criteria

The subjects with schizophrenia, mood disorder, dementia, neurodevelopmental disorders and their controls.

Key exclusion criteria

Those who are unable to give informed consent form, enter MRI scanner. Pregnant woman

Target sample size



Research contact person

Name of lead principal investigator

1st name Norio
Middle name
Last name Ozaki

Organization

Nagoya University

Division name

Graduate School of Medicine

Zip code

466-8550

Address

65 Tsurumai, Showa, Nagoya, Aichi, Japan

TEL

052-744-2282

Email

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


Public contact

Name of contact person

1st name Norio
Middle name
Last name Ozaki

Organization

Nagoya University

Division name

Graduate School of Medicine

Zip code

466-8550

Address

65 Tsurumai, Showa, Nagoya, Aichi, Japan

TEL

052-744-2282

Homepage URL


Email

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


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Strategic Research program for Brain 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

Nagoya University School of Medicine, Ethics Committee

Address

65, Tsurumai, Showa, Nagoya, Aichi, Japan

Tel

052-741-2111

Email

center-irb@med.nagoya-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

2015 Year 09 Month 30 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


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

Open public recruiting

Date of protocol fixation

2013 Year 05 Month 16 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Those who met our criteria have been used as the subjects in the experiment. Brain volumes, activation, and neuronal tract as measured by MRI have been compared bwteen the schizophreniac subject and normal controls.


Management information

Registered date

2015 Year 09 Month 30 Day

Last modified on

2022 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022162


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name