UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050601 |
|---|---|
| Receipt number | R000057634 |
| Scientific Title | Exploratory Study on Changes in Blood and Brain Metabolites Before and After Modified Electroconvulsive Therapy |
| Date of disclosure of the study information | 2023/03/20 |
| Last modified on | 2023/03/15 17:54:13 |
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Basic information
Public title
Comparative Study of Changes in Metabolites Before and After Modified Electroconvulsive Therapy
Acronym
Comparison of Metabolites Before and After mECT
Scientific Title
Exploratory Study on Changes in Blood and Brain Metabolites Before and After Modified Electroconvulsive Therapy
Scientific Title:Acronym
Exploratory Study on Changes in Metabolites Before and After mECT
Region
| Japan |
Condition
Condition
schizophrenia, major depression, bipolar disorder, catatonia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze changes in metabolites before and after electroconvulsive therapy using metabolomic analysis and MR spectroscopy, and to identify metabolites associated with therapeutic effects.
Basic objectives2
Others
Basic objectives -Others
Exploratory observational study before and after treatment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood metabolites and brain metabolites.
Key secondary outcomes
PANSS, HAM-D, MMSE, HDS-R, GAF, DIEPSS, ECT dose, fMRI, NIRS
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons undergoing ECT for the purpose of treating depression, bipolar disorder, schizophrenia, or catatonia.
Key exclusion criteria
People with physical diseases that affect blood metabolites, such as kidney or liver disorders.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
Shinshu University
Division name
Department of Community Mental Health
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263372638
kazsuzuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
Shinshu University
Division name
Department of Community Mental Health
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263372638
Homepage URL
kazsuzuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
3-1-1, Asahi, Matsumoto, Nagano
Tel
0263372638
kazsuzuki@shinshu-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
| 2023 | Year | 03 | Month | 20 | 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
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Metabolites in blood and brain using MRS
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057634
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
