UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the large-scale Neural Networks of Psychiatric disorders
Title of the study (Brief title)	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	Koichi Kaneko
Organization	Tottori University Faculty of Medicine
Division name	Division of Neuropsychiatry, Department of Brain and Neuroscience
Address	36-1 Nishi-cho, Yonago, Tottori
TEL	0859-38-6547
Email	kaneko@med.tottori-u.ac.jp

Public contact
Name of contact person	Shenghong Pu
Organization	Tottori University Faculty of Medicine
Division name	Division of Neuropsychiatry, Department of Brain and Neuroscience
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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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