UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Routine use of BIS Monitor on Seizure Quality in Electroconvulsive Therapy. A Pilot Study
Title of the study (Brief title)	ECT BIS a pilot study
Region	Japan

Condition
Condition	Mental disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether routine use of BIS monitor affects the quality of seizure quality in patients undergoing ECT
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Seizure quality
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	NO
Dynamic allocation
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Use of BIS monitor
Interventions/Control_2	Non use of BIS monitor
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 receive 2-3/week, more than 4 consecutive ECT sessions
Key exclusion criteria	Patients who can not be applied BIS monitor
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroshi Morisaki
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Address	35 Shinanomachi, Shinjukuku Tokyo, Japan
TEL	03-3353-1211
Email	morisaki@z8.keio.jp

Public contact
Name of contact person	Hiroyuki Seki
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Address	35 Shinanomachi Shinjukuku, Tokyo Japan
TEL	03-3353-1211
Homepage URL
Email	hseki.a3@keio.jp

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

Funding Source
Organization	Department of Anesthesiology, Keio University School of Medicine
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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 27 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 06 Month 27 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 05 Month 04 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031216