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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029134
Receipt No. R000033305
Scientific Title Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy
Date of disclosure of the study information 2017/09/14
Last modified on 2019/02/21

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Basic information
Public title Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy
Acronym Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy
Scientific Title Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy
Scientific Title:Acronym Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy
Region
Japan

Condition
Condition According to the diagnostic criteria for mood (affective) disorders:ICD-10
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of impedance-reduction between PreTac(skin preparatory solution to remove sebum) and Grad Z-101BA(salt-infused gel applied between electric pad and skin).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Static impedance (measured with 6 microampere) at placing electrodes on the patient skin and dynamic impedance (measured with 0.9 ampere) during administrating electric current to the brain.
Key secondary outcomes Number of times spent with saimapad
and Postictal Suppression Index (decrease in value immediately after the attack, completed average amplitude of 3 seconds between viewed in percent as reduced the average amplitude of the maximum amplitude of the seizure during 3 seconds, which one of the indicators of the quality of the attack)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Installing using drugs used saimapad in modified electroconvulsive therapy in the study subjects 10.
The modified electroconvulsive therapy and other enforcement procedures there is no difference.
(1) odd times:PreTac liquid
(2) even once: Grad Z-101BA
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 Study participants shall meet all the following criteria.
(1)Persons diagnosed with F3 mood (affective) disorders ICD-10 diagnostic criteria using
(2)Persons wearing saimapad on the bilateral side head, carried a modified electroconvulsive therapy
(3)Agree to the proposed person or obtained from the Novotel (spouse, brothers and sisters, his lineal relative within the relatives, guardian or curator shall)
Key exclusion criteria Otherwise excluded from study participants.
(1) if the person or from the Novotel was discontinued participation in research proposal
(2) in the PreTac fluid and Gerad Z-101BA until now or further if any allergic symptoms
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Miyaoka
Organization Kitasato University East hospital
Division name Department of Psychiatry
Zip code
Address 2-1-1 Asamizodai,Minami-ku, Sagamihara-shi, Kanagawa 252-0380, Japan
TEL 042-748-9111
Email miyaoka@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoya Shimano
Organization Kitasato University East hospital
Division name Department of Psychiatry
Zip code
Address 2-1-1 Asamizodai,Minami-ku, Sagamihara-shi, Kanagawa 252-0380, Japan
TEL 042-748-9111
Homepage URL
Email dm17013@st.kitasato-u.ac.jp

Sponsor
Institute Department of Pychiatry, Kitasato University East hospital
Institute
Department

Funding Source
Organization Department of Pychiatry, Kitasato University East hospital
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
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 北里大学東病院(神奈川県)/ Kitasato University East hospital (Kanagawa Prefecture

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 14 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 Completed
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 22 Day
Last follow-up date
2019 Year 02 Month 21 Day
Date of closure to data entry
2019 Year 02 Month 21 Day
Date trial data considered complete
2019 Year 02 Month 21 Day
Date analysis concluded
2019 Year 02 Month 21 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 13 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033305

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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