UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Imaging and epigenetic study for the therapeutic mechanism of ECT in the treatment of referactory depression
Title of the study (Brief title)	Imaging and epigenetic study of ECT
Region	Japan

Condition
Condition	Refractory depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the therapeutic mechanism of ECT in the treatment of refractory depressin using functional connectivity measured by fMRI and DNA methylation.
Basic objectives2	Others
Basic objectives -Others	To develop the prognostic biomarker in the treatment of feractory depressin in response to ECT
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Hamilton rating scale for depression Functinal connectivity analysis DNA methylation Outcome measurement is done 1 day and 3 months after the final ECT.
Key secondary outcomes

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Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Electoric convulsive therapy (Twice/week, Total 10 times, Duration 5 weeks)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with major depression diagnosed by DSM-V and MINI. They did not respond to appropriate antidepressant treatments.
Key exclusion criteria	Patients with major depression and other psychiatric disorders. Patients with major organic brain disorders. Patients who did not met ECT criteria due to physical illness.
Target sample size	20

Research contact person
Name of lead principal investigator	Shigeru Morinobu
Organization	Kochi University
Division name	Dept. neuropsychiatry, Med. Sch.
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	088-880-2359
Email	smorinob@kochi-u.ac.jp

Public contact
Name of contact person	Shigeru Morinobu
Organization	Kochi University
Division name	Dept. Neuropsychiatry, Med. Sch.
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	088-880-2359
Homepage URL	https://kochi.neuropsychiatry/
Email	smorinob@kochi-u.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, Kochi Medical School, Kochi University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Neuropsychiatry, Kochi Medical School, Kochi University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kochi University of Technology
Name of secondary funｄer(s)	No

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	高知大学病院（高知県）、高知工科大学（高知県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 06 Month 09 Day
Anticipated trial start date	2013 Year 10 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	2016 Year 07 Month 16 Day
Last modified on	2016 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026690