UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048979 |
|---|---|
| Receipt number | R000055802 |
| Scientific Title | A clinical research on psychiatric disorders based on networks and metabolite status in the brain |
| Date of disclosure of the study information | 2022/09/21 |
| Last modified on | 2023/03/19 11:12:52 |
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Basic information
Public title
A clinical research on psychiatric disorders based on networks and metabolite status in the brain
Acronym
A clinical research on psychiatric disorders based on networks and metabolite status in the brain
Scientific Title
A clinical research on psychiatric disorders based on networks and metabolite status in the brain
Scientific Title:Acronym
A clinical research on psychiatric disorders based on networks and metabolite status in the brain
Region
| Japan |
Condition
Condition
psychiatric disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate pathophysiology of psychiatric disorders based on networks and metabolite status in the brain
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
indices of structural and functional brain networks, and neurometabolites measured by MRI
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
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
healthy controls
Interventions/Control_2
patients with psychiatric disorders
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who can understand the content of this study.
Each patient mush meet the diagnostic criterion.
Key exclusion criteria
Subjects with severe neurological diseases
Subjects without sufficient capacity to consent due to medical conditions, etc.
Subjects with contraindication to MRI imaging
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kubota |
Organization
Kyoto University
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3386
m_kubota@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Kubota |
Organization
Kyoto University
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3386
Homepage URL
kupsy.research8@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of 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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2022 | Year | 09 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055802
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
