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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041989
Receipt No. 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

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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
Email 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
Email dhayashi@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047923

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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