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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027105
Receipt No. R000030862
Scientific Title Multimodal observation study on electroconvulsive therapy.
Date of disclosure of the study information 2017/04/24
Last modified on 2017/04/24

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Basic information
Public title Multimodal observation study on electroconvulsive therapy.
Acronym Multimodal observation study on electroconvulsive therapy.
Scientific Title Multimodal observation study on electroconvulsive therapy.
Scientific Title:Acronym Multimodal observation study on electroconvulsive therapy.
Region
Japan

Condition
Condition Depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidation of the mechanism of electroconvulsive therapy
Basic objectives2 Others
Basic objectives -Others Elucidation of the mechanism of electroconvulsive therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sequential change of representative index obtained by each examination (MRI, NIRS, EEG), series of ECT treatment.
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Who met the criteria for a depressive episode (either unipolar or bipolar disorder)
2) Who were scheduled to undergo electroconvulsive therapy at Keio University Hospital in Japan.
3) Who were judged by the attending physician that Informed consent can be acquired
Key exclusion criteria 1)Stupor
2)With internal metals or pacemakers
3)Unstable medical condition
4)History of significant head trauma.
5)Pregnant
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Uchida
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-5363-3829
Email hiroyuki.uchida.hu@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Jinichi Hirano
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-5363-3829
Homepage URL
Email hjinichi@keio.jp

Sponsor
Institute Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 24 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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Three times NIRS scanning, MRI imaging, Electroencepharograh are performed. Scan timing is before the course of ECT treatment, after three sessions of ECT and after the series of ECT treatment.

Management information
Registered date
2017 Year 04 Month 24 Day
Last modified on
2017 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030862

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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