UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041989 |
|---|---|
| Receipt number | R000047923 |
| Scientific Title | A retrospective observational study of the efficacy of electroconvulsive therapy for mental disorders |
| Date of disclosure of the study information | 2020/10/02 |
| Last modified on | 2020/10/02 17:55:25 |
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Basic information
Public title
A retrospective observational study of the efficacy of electroconvulsive therapy for mental disorders
Acronym
EffECT
Scientific Title
A retrospective observational study of the efficacy of electroconvulsive therapy for mental disorders
Scientific Title:Acronym
EffECT
Region
| Japan |
Condition
Condition
Mental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness of electroconvulsive therapy for mental disorders
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute electroconvulsive therapy : change in Clinical Global Impressions severity of illness scale (CGI I)
Maintenance electroconvulsive therapy : number of days from introduction of maintenance electroconvulsive therapy to re-exacerbation
Key secondary outcomes
Acute electroconvulsive therapy : Clinical Global Impressions improvement scale (CGI I)
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
Patients who received ECT at the National Center of Neurology and Psychiatry Hospital during the study period of April 1, 2014 to March 31, 2 020.
Key exclusion criteria
None
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Kito |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Psychiatry
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
042-341-2711
kito@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hayashi |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Psychiatry
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
042-341-2711
Homepage URL
dhayashi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
Ogawa-Higashi 4-1-4, Kodaira, Tokyo 187-8551, Japan
Tel
042-341-2712
rinri-jimu@ncnp.go.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
| 2020 | Year | 10 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 02 | 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
Collecting data now
Management information
Registered date
| 2020 | Year | 10 | Month | 02 | Day |
Last modified on
| 2020 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047923
| 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 |
