UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043472 |
|---|---|
| Receipt number | R000049627 |
| Scientific Title | The effect of anesthesia-stimulation time on the seizure quality in electroconvulsive therapy: a single-blind, parallel-group, randomized controlled trial |
| Date of disclosure of the study information | 2021/02/28 |
| Last modified on | 2026/09/03 15:24:34 |
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Basic information
Public title
The effect of anesthesia-stimulation time on the seizure quality in electroconvulsive therapy: a single-blind, parallel-group, randomized controlled trial
Acronym
The effect of anesthesia-stimulation time on the seizure quality in ECT: a single-blind, parallel-group, RCT
Scientific Title
The effect of anesthesia-stimulation time on the seizure quality in electroconvulsive therapy: a single-blind, parallel-group, randomized controlled trial
Scientific Title:Acronym
The effect of anesthesia-stimulation time on the seizure quality in ECT: a single-blind, parallel-group, RCT
Region
| Japan |
Condition
Condition
ECT-adapted disorders such as depression, bipolar disorder, schizophrenia, schizoaffective disorder and catatonia
Classification by specialty
| Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The time interval from anesthesia to the electrical stimulation (ASTI) indirectly reflects the drug concentration in the brain of the anesthetic and is, therefore, an important factor in determining whether or not a seizure occurs. The time interval from anesthesia to the electrical stimulation (AETI) indirectly reflects the concentration of anesthetic drugs in the brain and is an important factor in determining whether or not a seizure occurs. In this study, the investigators will investigate the relationship between AETI and seizure quality, efficacy, and tolerability in a single-blind, parallel-group study, and evaluate and analyze each context. The aim is to contribute to the optimization of treatment algorithms and the establishment of an effective therapeutic platform so that patients can benefit consistently from ECT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Seizure Quality in ECT
Key secondary outcomes
Assessment of the severity of each disease
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Anesthesia to stimulation time is 150 seconds
Interventions/Control_2
Anesthesia to stimulation time is 240 seconds
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients for whom ECT is indicated according to the "ECT Practice Guide" in the APA Task Force Report (main diagnoses for which ECT is indicated: catatonia, major depressive disorder, mania, schizophrenia, etc.)
(2) Patients who have given consent for ECT from the subject himself/herself or a substitute (family member, etc.) at the time of obtaining research consent
Key exclusion criteria
(1) Patients who are judged to be difficult to undergo ECT due to complications such as physical symptoms.
(2) Patients who are judged inappropriate for this study by the physician in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobuatsu |
| Middle name | |
| Last name | Aoki |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
5708506
Address
10-15 Fumizoon-cho, Moriguchi-shi, Osaka prefecture
TEL
0669921001
aokinob@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Aoki |
| Middle name | |
| Last name | Nobuatsu |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
5708596
Address
10-15 Fumizoon-cho, Moriguchi-shi, Osaka prefecture
TEL
09077604177
Homepage URL
aokinob@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
This work was supported by KAKENHI Grants-in-Aid for Scientific Research C (19K08031) from JSPS.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Neuropsychiatry, Graduate School of Medicine, Kyoto University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Neuropsychiatry, Kansai Medical University
Address
10-15 Fumizoon-cho, Moriguchi-shi, Osaka prefecture
Tel
09077604177
aokinob@takii.kmu.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
| 2021 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://nrid.nii.ac.jp/nrid/1000080343672/
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
| 2018 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 17 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 24 | Day |
Date analysis concluded
| 2026 | Year | 10 | Month | 15 | Day |
Other
Other related information
Enrolment was closed before the planned sample size was reached.
The initial target was 50 patients (25 per group). The sample size was calculated on ECT
sessions and required 620 sessions in total (310 per group). Forty-five patients were
randomised (22 to the 150 s interval and 23 to the 240 s interval).
Enrolment was closed for feasibility alone.
(1) The calculation had assumed an uncapped course, whereas the protocol limited each course to eight sessions; the mean number of analysable sessions was 6.1 per patient, so that 620 sessions would have required approximately 100 patients.
(2) The COVID-19 pandemic disrupted the provision of ECT and prevented the intended
multicentre collaboration, so that the coordinating centre enrolled the entire sample.
The decision was made under the provision of the protocol for discontinuation when the
planned sample cannot feasibly be attained, and was not based on accumulating efficacy or
safety data. No interim analysis was pre-specified and no stopping rule was applied at any point. An exploratory analysis of the earlier participants was presented in abstract form at a scientific meeting in 2023; enrolment continued for three years thereafter, and that analysis had no bearing on the decision to close enrolment.
Management information
Registered date
| 2021 | Year | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049627
| Research Plan | |
|---|---|
| Registered date | File name |
| 2026/08/23 | AETI研究計画書 1_Apr_24.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2026/08/23 | Data仕様書.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2026/08/23 | AETI_研究症例data.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/49627
