UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027247 |
|---|---|
| Receipt number | R000031216 |
| Scientific Title | Effect of Routine use of BIS Monitor on Seizure Quality in Electroconvulsive Therapy. A Pilot Study |
| Date of disclosure of the study information | 2017/06/27 |
| Last modified on | 2018/01/31 19:57:31 |
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Basic information
Public title
Effect of Routine use of BIS Monitor on Seizure Quality in Electroconvulsive Therapy. A Pilot Study
Acronym
ECT BIS a pilot study
Scientific Title
Effect of Routine use of BIS Monitor on Seizure Quality in Electroconvulsive Therapy. A Pilot Study
Scientific Title:Acronym
ECT BIS a pilot study
Region
| Japan |
Condition
Condition
Mental disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether routine use of BIS monitor affects the quality of seizure quality in patients undergoing ECT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Seizure quality
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Use of BIS monitor
Interventions/Control_2
Non use of BIS monitor
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
Patients who receive 2-3/week, more than 4 consecutive ECT sessions
Key exclusion criteria
Patients who can not be applied BIS monitor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Morisaki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
35 Shinanomachi, Shinjukuku Tokyo, Japan
TEL
03-3353-1211
morisaki@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Seki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
35 Shinanomachi Shinjukuku, Tokyo Japan
TEL
03-3353-1211
Homepage URL
hseki.a3@keio.jp
Sponsor or person
Institute
Department of Anesthesiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Keio University School of Medicine
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
Address
Tel
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
| 2017 | Year | 06 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 04 | Day |
Last modified on
| 2018 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031216
