UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037775 |
|---|---|
| Receipt number | R000043078 |
| Scientific Title | A MRI study to elucidate the pathophysiology of neurological and psychiatric diseases |
| Date of disclosure of the study information | 2019/09/30 |
| Last modified on | 2019/12/11 17:35:22 |
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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
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
psy_jimu@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043078
