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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023603
Receipt No. R000027177
Scientific Title A Study on the large-scale Neural Networks of Psychiatric disorders
Date of disclosure of the study information 2016/08/15
Last modified on 2016/08/12

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Basic information
Public title A Study on the large-scale Neural Networks of Psychiatric disorders
Acronym A Study on the large-scale Neural Networks of Psychiatric disorders
Scientific Title A Study on the large-scale Neural Networks of Psychiatric disorders
Scientific Title:Acronym A Study on the large-scale Neural Networks of Psychiatric disorders
Region
Japan

Condition
Condition Schizophrenia
Autism spectrum disorder
Major depressive disorder
Bipolar disorders
Healthy control
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is a study of patients with psychiatric disorders, which examines the failure of connectivity between structural and functional large-scale neural networks related to psychiatric symptoms, cognitive functions, and social functions (objective and subjective assessments), using diffusion tensor imaging (DTI) and resting-state functional MRI (rs-fMRI).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fMRI,DTI
Key secondary outcomes Psychiatric symptoms, cognitive functions, and social functions (objective and subjective assessments)

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 fMRI,DTI,neuropsychological test
Interventions/Control_2 fMRI,DTI,neuropsychological test
Interventions/Control_3 fMRI,DTI,neuropsychological test
Interventions/Control_4 fMRI,DTI,neuropsychological test
Interventions/Control_5 fMRI,DTI,neuropsychological test
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients who are diagnosed with unipolar melancholic depression, bipolar disorder, schizophrenia, or autistic spectrum disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
2. Patients between the ages of 16-65.
3. Patients who scored higher than 70 of estimated premorbid IQ in JART (Japanese Adult Reading Test).
4. Patients (their parents or guardians, in the case of minors) who have given informed consent to participate in research.
Key exclusion criteria 1.Patients who have strong suicidal ideation.
2.Patients who are currently being treated for alcohol/drug abuse.
3.Patients with a history of head injury with loss of consciousness.
4.Patients who have serious physical illness.
5.Patients who cannot be examined by MRI (due to metallic implants, tattoos, or claustrophobia).
6.Patients who were determined by their doctors or head researchers to be inappropriate for research subjects for other reasons.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Kaneko
Organization Tottori University Faculty of Medicine
Division name Division of Neuropsychiatry, Department of Brain and Neuroscience
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori
TEL 0859-38-6547
Email kaneko@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shenghong Pu
Organization Tottori University Faculty of Medicine
Division name Division of Neuropsychiatry, Department of Brain and Neuroscience
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori
TEL 0859-38-6547
Homepage URL
Email pshh0517@yahoo.co.jp

Sponsor
Institute Tottori University faculty of Medicine
Institute
Department

Funding Source
Organization Ministry of education, culture, sports, science and technology, JAPAN
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Tottori University Faculty of Medicine

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 鳥取大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 08 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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 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
2016 Year 08 Month 12 Day
Last modified on
2016 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027177

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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