UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multimodal observation study on electroconvulsive therapy.
Title of the study (Brief title)	Multimodal observation study on electroconvulsive therapy.
Region	Japan

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

Objectives
Narrative objectives1	Elucidation of the mechanism of electroconvulsive therapy
Basic objectives2	Others
Basic objectives -Others	Elucidation of the mechanism of electroconvulsive therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sequential change of representative index obtained by each examination (MRI, NIRS, EEG), series of ECT treatment.
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)Who met the criteria for a depressive episode (either unipolar or bipolar disorder) 2) Who were scheduled to undergo electroconvulsive therapy at Keio University Hospital in Japan. 3) Who were judged by the attending physician that Informed consent can be acquired
Key exclusion criteria	1)Stupor 2)With internal metals or pacemakers 3)Unstable medical condition 4)History of significant head trauma. 5)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, 160-8582, Japan
TEL	03-5363-3829
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, 160-8582, Japan
TEL	03-5363-3829
Homepage URL
Email	hjinichi@keio.jp

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

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 04 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 24 Day
Anticipated trial start date	2017 Year 04 Month 25 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	Three times NIRS scanning, MRI imaging, Electroencepharograh are performed. Scan timing is before the course of ECT treatment, after three sessions of ECT and after the series of ECT treatment.

Management information
Registered date	2017 Year 04 Month 24 Day
Last modified on	2017 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030862