UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010716
Receipt number R000012524
Scientific Title The study of functional magnetic resonance imaging for the evaluation of the neural basis of the symptoms and state of mental illness.
Date of disclosure of the study information 2013/05/15
Last modified on 2017/05/17 18:14:30

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Basic information

Public title

The study of functional magnetic resonance imaging for the evaluation of the neural basis of the symptoms and state of mental illness.

Acronym

fMRI study for neural basis of the mental illness.

Scientific Title

The study of functional magnetic resonance imaging for the evaluation of the neural basis of the symptoms and state of mental illness.

Scientific Title:Acronym

fMRI study for neural basis of the mental illness.

Region

Japan


Condition

Condition

healthy volunteer
schizophrenia
mood disorders
neurotic disorders
disorders of psychological development
behavioural and emotional disorders

Classification by specialty

Pediatrics Psychiatry Adult
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the neural basis of the mental illness by multi-modality of magnetic resonance imaging.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change of signal of brain morphometry, difussion tensor imagign, neuromelanin imaging, and functional magnetic resonance imaging.

Key secondary outcomes

neuropsychological examination


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

MRI, neuropsychological batteries

Interventions/Control_2

MRI, neuropsychological batteries

Interventions/Control_3

MRI, neuropsychological batteries

Interventions/Control_4

MRI, neuropsychological batteries

Interventions/Control_5

MRI, neuropsychological batteries

Interventions/Control_6

MRI, neuropsychological batteries

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy volunteers
- without past or current history of mental illnesses

illnesses groups
- who met the diagnostic criteria of F2, F3, F4, F8, F9 code of ICD-10

Key exclusion criteria

Exclusion criteria:
- With past or current history of serious medical illness and/or brain organic diseases
- Subject who is contraindicated for the use of MRI
- With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- Subjects who are judged as not suitable for participation in this study

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiro Okubo, MD., Ph.D.

Organization

Nippon Medical School

Division name

Department of Neuropsychiatry

Zip code


Address

1-1-5 Sendagi, Bunkyo-ku, Tokyom 113-8603, Japan

TEL

03-3822-2131

Email

okubo-y@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Amane Tateno, M.D., Ph.D.

Organization

Nippon Medical School

Division name

Department of Neuropsychiatry

Zip code


Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan

TEL

03-3822-2131

Homepage URL


Email

amtateno@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

日本医科大学付属病院精神神経科、日本医科大学薬理学教室、日本医科大学健診医療センター、玉川大学・脳科学研究所、八重洲クリニック


Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 15 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

Completed

Date of protocol fixation

2013 Year 05 Month 14 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 16 Day

Last follow-up date

2016 Year 04 Month 30 Day

Date of closure to data entry

2016 Year 05 Month 31 Day

Date trial data considered complete

2016 Year 07 Month 31 Day

Date analysis concluded

2016 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 05 Month 14 Day

Last modified on

2017 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012524


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name