UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of anesthetics on depression after modified electroconvulsive treatment
Title of the study (Brief title)	ECT a cross-over test
Region	Japan

Condition
Condition	severe depression
Classification by specialty	Psychiatry Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of ketamine on depression after modified electroconvulsive treatment.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	HAM-D((Hamilton depression score)
Key secondary outcomes	Pupil diameter measurement Hear rate viriability

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	GroupA) Propofol is used in the former half of the period and ketamine is used in the latter half of the period, during ECT procedure.
Interventions/Control_2	GroupB) Ketamine is used in the former half of the period and propofol is used in the latter half of the period, during ECT procedure.
Interventions/Control_3	GroupA) Only propofol is used in the former half of the period and combination of ketamine and propofol is used in the latter half of the period, during ECT procedure.
Interventions/Control_4	GroupB) Only ketamine is used in the former half of the period and combination of ketamine and propofol is used in the latter half of the period, during ECT procedure.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	severe depression
Key exclusion criteria	1)Patients with mandatory admission 2)ECT procedure with other procedure 3)Patients with severe coronary artery disease or cerebrovascular disease 4)Severe liver dysfunction 5)Patients with hemodialysis 6)Patients with a permanent pacemaker 7)BMI(Body Mass Index) more than 35 or equal to 35 8)The patient involved in other randomized trail using drugs 9)Patients who were judged as inappropriate by doctors working for this trail
Target sample size	80

Research contact person
Name of lead principal investigator	Shoko Nakano
Organization	Osaka Medical College
Division name	Department of Anesthesiology
Address	2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL	072-683-1221
Email	ane060@osaka-med.ac.jp

Public contact
Name of contact person	Junko Nakahira
Organization	Osaka Medical College
Division name	Department of Anestheisology
Address	2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	ane052@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	大阪医科大学付属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 07 Month 06 Day
Anticipated trial start date	2016 Year 07 Month 07 Day
Last follow-up date	2016 Year 09 Month 06 Day
Date of closure to data entry	2016 Year 09 Month 06 Day
Date trial data considered complete	2016 Year 09 Month 06 Day
Date analysis concluded	2016 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study was terminated, because results of the same study has been published.

Management information
Registered date	2015 Year 06 Month 16 Day
Last modified on	2016 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020766