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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014756
Receipt No. R000017099
Scientific Title A high-resolution MRI analysis in psychiatric disorders
Date of disclosure of the study information 2014/08/05
Last modified on 2017/02/27

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Basic information
Public title A high-resolution MRI analysis in psychiatric disorders
Acronym A high-resolution MRI analysis in psychiatric disorders
Scientific Title A high-resolution MRI analysis in psychiatric disorders
Scientific Title:Acronym A high-resolution MRI analysis in psychiatric disorders
Region
Japan

Condition
Condition Healthy control
Schizophrenia
Mood disorder
Epilepsy
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the neural basis of psychiatric disorders and establish an objective indicator that is useful for early diagnosis and screening by detailed structural analysis of the brain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes volumes of region of interest
Key secondary outcomes FA(fractional anisotropy)
PANSS
SAPS
SANS
SES(socioeconomic status)

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 5
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 MRI,neuropsychological test
Interventions/Control_2 MRI,neuropsychological test
Interventions/Control_3 MRI,neuropsychological test
Interventions/Control_4 MRI,neuropsychological test
Interventions/Control_5 MRI,neuropsychological test
Interventions/Control_6
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 1) Right-handed
2) Inpatients or outpatients of Kyushu-university hospital
those who are diagnosed by DSM-4, and ICD-10
Key exclusion criteria 1) Subjects with neurological illness or major head trauma
2) Subjects with alcohol or drug abuse within the past five years
3) Subjects with a verbal intelligence quotient below 75
4) Healthy controls with Axis 1 disorder in themselves or a first-degree relative, which were screened using the Structured Clinical Interview (SCID), non-patient edition.
5) Subjects who have contraindication to MRI
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigenobu Kanba
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Neuropsychiatry
Zip code
Address Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL 092-641-1151
Email skanba@npsych.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Onitsuka
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Neuropsychiatry
Zip code
Address Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL 092-641-1151
Homepage URL
Email toshiaki@npsych.med.kyushu-u.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 05 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
2014 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 04 Day
Last modified on
2017 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017099

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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