UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017924 |
|---|---|
| Receipt number | R000020766 |
| Scientific Title | Effects of anesthetics on depression after modified electroconvulsive treatment |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2016/12/16 09:27:37 |
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Basic information
Public title
Effects of anesthetics on depression after modified electroconvulsive treatment
Acronym
ECT a cross-over test
Scientific Title
Effects of anesthetics on depression after modified electroconvulsive treatment
Scientific Title:Acronym
ECT a cross-over test
Region
| Japan |
Condition
Condition
severe depression
Classification by specialty
| Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of ketamine on depression after modified electroconvulsive treatment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HAM-D((Hamilton depression score)
Key secondary outcomes
Pupil diameter measurement
Hear rate viriability
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GroupA) Propofol is used in the former half of the period and ketamine is used in the latter half of the period, during ECT procedure.
Interventions/Control_2
GroupB) Ketamine is used in the former half of the period and propofol is used in the latter half of the period, during ECT procedure.
Interventions/Control_3
GroupA) Only propofol is used in the former half of the period and combination of ketamine and propofol is used in the latter half of the period, during ECT procedure.
Interventions/Control_4
GroupB) Only ketamine is used in the former half of the period and combination of ketamine and propofol is used in the latter half of the period, during ECT procedure.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
severe depression
Key exclusion criteria
1)Patients with mandatory admission
2)ECT procedure with other procedure
3)Patients with severe coronary artery disease or cerebrovascular disease
4)Severe liver dysfunction
5)Patients with hemodialysis
6)Patients with a permanent pacemaker
7)BMI(Body Mass Index) more than 35 or equal to 35
8)The patient involved in other randomized trail using drugs
9)Patients who were judged as inappropriate by doctors working for this trail
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoko Nakano |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
ane060@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Nakahira |
Organization
Osaka Medical College
Division name
Department of Anestheisology
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
ane052@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
大阪医科大学付属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 06 | 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
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 06 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 06 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 06 | Day |
Other
Other related information
This study was terminated, because results of the same study has been published.
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2016 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020766
| Research Plan | |
|---|---|
| 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 |
