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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016134
Receipt No. R000018731
Scientific Title Investigation of biomarkers of multiple psychiatric disorders based on the analyses of large-scale MRI data
Date of disclosure of the study information 2015/01/07
Last modified on 2019/11/13

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Basic information
Public title Investigation of biomarkers of multiple psychiatric disorders based on the analyses of large-scale MRI data
Acronym Investigation of biomarkers of multiple psychiatric disorders based on the analyses of large-scale MRI data
Scientific Title Investigation of biomarkers of multiple psychiatric disorders based on the analyses of large-scale MRI data
Scientific Title:Acronym Investigation of biomarkers of multiple psychiatric disorders based on the analyses of large-scale MRI data
Region
Japan

Condition
Condition Autism spectrum disorder
Schizophrenia
Depression
Attention deficit hyperactivity disorder
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the biomarkers of psychiatric disorders (autism spectrum disorder, schizophrenia, depression, and attention deficit hyperactivity disorder) using large-scale MRI data.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Multi-modal MRI (fMRI, sMRI, DTI, and MRS), physiological data, and psychological tests
Key secondary outcomes

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Individuals with autism spectrum disorder
Interventions/Control_2 Individuals with schizophrenia
Interventions/Control_3 Individuals with depression
Interventions/Control_4 Healthy controls
Interventions/Control_5 Individuals with attention deficit hyperactivity disorder
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Patients
1) Individuals who is diagnosed as autism spectrum disorder, schizophrenia, or depression, based on DSM-IV-TR
2) Individuals who do not have any other neurological or psychiatric disorders
3) Individuals who have capability of informed consent
Key exclusion criteria Patients and healthy controls
1) with implanted cardiac pacemaker
2) with surgical aneurysm clips
3) with neurostimulator
4) with implanted pumps
5) with metal fragments in body
6) with tattoos, permanent eyeliner (if ink contains metallic specks)
7) with pregnancy and at risk of becoming pregnant
8) Subjects who are judged as unsuitable for participation in this study by their primary doctor (patients only)
Target sample size 690

Research contact person
Name of lead principal investigator
1st name Nobumasa
Middle name
Last name Kato
Organization Showa University
Division name Medical Institute of Developmental Disabilities Research
Zip code 157-0057
Address 6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo
TEL 03-3300-5231
Email katon@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Itahashi
Organization Showa University
Division name Medical Institute of Developmental Disabilities Research
Zip code 157-0057
Address 6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo
TEL 03-3300-5231
Homepage URL http://www10.showa-u.ac.jp/~BIRC/
Email ita3@med.showa-u.ac.jp

Sponsor
Institute Medical Institute of Developmental Disabilities Research, Showa University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Showa University, Karasuyama Hospital
Address 6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo,157-8577 Japan
Tel 03-3300-5247
Email showa-crc@ofc.showa-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 01 Month 07 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 Enrolling by invitation
Date of protocol fixation
2015 Year 01 Month 05 Day
Date of IRB
2014 Year 12 Month 26 Day
Anticipated trial start date
2015 Year 01 Month 06 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

Management information
Registered date
2015 Year 01 Month 06 Day
Last modified on
2019 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018731

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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