UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-Modal study for the Maintenance of Remission after Electroconvulsive therapy (ECT)
Title of the study (Brief title)	Multi-Modal study for the Maintenance of Remission after Electroconvulsive therapy (ECT)
Region	Japan

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

Objectives
Narrative objectives1	To clarify the biological mechanisms of the keeping the remission after ECT
Basic objectives2	Others
Basic objectives -Others	To clarify the biological mechanisms of the keeping the remission after ECT
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the NIRS scan, electroencephalogram scan, MRI scan at discharge, between remission maintenance group (12 months after discharge) and relapsing group.
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, 20 years and over 2, Meet the criteria of major depression or bipolar depression by Diagnostic and Statistical Manual of Mental Disorders Fifth Edition 3, Remission state that is treated by the electroconvulsive therapy
Key exclusion criteria	1, With internal metals or pacemakers 2, With serious physical disorders 3, History of head injury with severe neurological sequelae 4, Pregnant
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroyuki Uchida
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3971
Email	hiroyuki.uchida.hu@gmail.com

Public contact
Name of contact person	Jinichi Hirano
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3971
Homepage URL
Email	hjinichi@gmail.com

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

Funding Source
Organization	Advanced Telecommunications Research Institute International
Organization
Division
Category of Funding Organization	Profit organization
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 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 20 Day
Anticipated trial start date	2017 Year 06 Month 09 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	MRI scan, EEG scan, NIRS scan, symptom assessment are performed at discharge from the hospital. In addition, symptom assessment and questionnaire survey will be conducted by postal mail, 6 and 12 months after discharge. For the cases agreeing to visit our site at 6 and 12 months after discharge, MRI scan, EEG scan, NIRS scan, symptom assessment are performed.

Management information
Registered date	2017 Year 06 Month 20 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031884