UMIN-CTR Clinical Trial

Basic information
Public title	A MRI study to elucidate the pathophysiology of neurological and psychiatric diseases
Acronym	A MRI study of neurological and psychiatric diseases
Scientific Title	A MRI study to elucidate the pathophysiology of neurological and psychiatric diseases
Scientific Title:Acronym	A MRI study of neurological and psychiatric diseases
Region	Japan

Condition
Condition	Patients with neurological and psychiatric diseases
Classification by specialty	Neurology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify differences and similarities of brain pathophysiology of neurological and psychiatric diseases measured by MRI.
Basic objectives2	Others
Basic objectives -Others	To explore biomakers of outcome.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify the diffences of brain structural abnormalities between patients with neurological diseases and those with psychiatric diseases
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	3
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Psychiatric diseases
Interventions/Control_2	Neurological diseases
Interventions/Control_3	Healthy subjects
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients diagnosed with parkinson disease, dementia with Lewy bodies, multiple system atrophy, progressive supranuclea palsy, corticobasal degeneration, epilepsy, depression, or bipolar disorder.
Key exclusion criteria	Subjets with low IQ or low education level Subjects with brain injury with loss of consciousness Subjects with seevere physical condition, kidney failure, or thyroid dysfuntion. Subjects who are considered to inadequate for study participants by researchers.
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Matsuo
Organization	Saitama Medical University Hosptal
Division name	Depatment of Psychiatry
Zip code	3500495
Address	38 Morohongo, Moroyama, Iruma, Saitama
TEL	0492761214
Email	kmatsuo@saitama-med.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Matsuo
Organization	Saitama Medical University Hospital
Division name	Department of Psychiatry
Zip code	3500495
Address	38 Morohongo, Moroyama, Iruma, Saitama
TEL	0492761214
Homepage URL
Email	psy_jimu@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board of Saitama Medical University Hospital
Address	38 Morohongo, Moroyama, Iruma, Saitama
Tel	0492761354
Email	hirb@saitama-med.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	2019 Year 09 Month 30 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	Open public recruiting
Date of protocol fixation	2019 Year 08 Month 31 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2019 Year 09 Month 30 Day
Last follow-up date	2030 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 22 Day
Last modified on	2019 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043078