UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050713 |
|---|---|
| Receipt number | R000057635 |
| Scientific Title | Association between brand-name or generic suxamethonium for modified electroconvulsive therapy and muscle relaxation: comparative effectiveness study |
| Date of disclosure of the study information | 2023/03/29 |
| Last modified on | 2024/02/06 18:45:13 |
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Basic information
Public title
Differences in efficacy between brand-name and generic suxamethonium in modified electroconvulsive therapy: a retrospective observational study
Acronym
Differences in efficacy between brand-name and generic suxamethonium in modified electroconvulsive therapy: a retrospective observational study
Scientific Title
Association between brand-name or generic suxamethonium for modified electroconvulsive therapy and muscle relaxation: comparative effectiveness study
Scientific Title:Acronym
Association between brand-name or generic suxamethonium for modified electroconvulsive therapy and muscle relaxation: comparative effectiveness study
Region
| Japan |
Condition
Condition
Diseases that require modified ECT for treatment
Classification by specialty
| Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine retrospectively whether the muscle relaxant effect of succinylcholine is equivalent between brand-name and generic drugs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ease of oral protector insertion is divided into three levels: excellent, good, or poor.
Key secondary outcomes
Complications, etc.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Psychiatric patients undergoing modified electroconvulsive therapy
Key exclusion criteria
Patients with contraindications to succinylcholine administration, patients with malignant syndromes, patients with a history or family history of malignant hyperthermia, and other patients for whom succinylcholine administration is considered contraindicated
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Mizuho |
| Middle name | |
| Last name | Matsui |
Organization
Seijin Hospital
Division name
Medical office
Zip code
1210815
Address
3-2-1 Shimane, Adachi-ku, Tokyo
TEL
050-3734-5401
ryosoclinic@gmail.com
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Matsui |
Organization
Seijin Hospital
Division name
Medical office
Zip code
1210815
Address
3-2-1 Shimane, Adachi-ku, Tokyo
TEL
050-3734-5401
Homepage URL
ryosoclinic@gmail.com
Sponsor or person
Institute
Seijin Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Seijin Hospital
Address
3-2-1 Shimane, Adachi-ku, Tokyo
Tel
050-3734-5401
ryosoclinic@gmail.com
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 | 29 | 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 | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Retrospective study.
Recruitment method: All patients who visited the hospital from March to May 2023 and met the selection criteria.
Management information
Registered date
| 2023 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057635
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
