UMIN-CTR Clinical Trial

Basic information
Public title	Functional and structural MRI study of mental disorders"
Acronym	MRI study
Scientific Title	Functional and structural MRI study of mental disorders"
Scientific Title:Acronym	MRI study
Region	Japan

Condition
Condition	Schizophrenia Mood disorder Autism Demrntia
Classification by specialty	Psychiatry Adult Child
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Investigate relathinship between mental disorders and brain structure/function
Basic objectives2	Others
Basic objectives -Others	Neuronal correlates of mental disorders
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brain structure and function as measured by MRI
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	6 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	The subjects with schizophrenia, mood disorder, dementia, neurodevelopmental disorders and their controls.
Key exclusion criteria	Those who are unable to give informed consent form, enter MRI scanner. Pregnant woman
Target sample size

Research contact person
Name of lead principal investigator	1st name Norio Middle name Last name Ozaki
Organization	Nagoya University
Division name	Graduate School of Medicine
Zip code	466-8550
Address	65 Tsurumai, Showa, Nagoya, Aichi, Japan
TEL	052-744-2282
Email	ozaki-n@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Norio Middle name Last name Ozaki
Organization	Nagoya University
Division name	Graduate School of Medicine
Zip code	466-8550
Address	65 Tsurumai, Showa, Nagoya, Aichi, Japan
TEL	052-744-2282
Homepage URL
Email	ozaki-n@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Strategic Research program for Brain Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nagoya University School of Medicine, Ethics Committee
Address	65, Tsurumai, Showa, Nagoya, Aichi, Japan
Tel	052-741-2111
Email	center-irb@med.nagoya-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 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Open public recruiting
Date of protocol fixation	2013 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date	2013 Year 05 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Those who met our criteria have been used as the subjects in the experiment. Brain volumes, activation, and neuronal tract as measured by MRI have been compared bwteen the schizophreniac subject and normal controls.

Management information
Registered date	2015 Year 09 Month 30 Day
Last modified on	2022 Year 04 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022162