UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy
Title of the study (Brief title)	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	Hitoshi Miyaoka
Organization	Kitasato University East hospital
Division name	Department of Psychiatry
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	Tomoya Shimano
Organization	Kitasato University East hospital
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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