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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023198
Receipt No. R000026690
Scientific Title Imaging and epigenetic study for the therapeutic mechanism of ECT in the treatment of referactory depression
Date of disclosure of the study information 2016/07/25
Last modified on 2016/07/16

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Basic information
Public title Imaging and epigenetic study for the therapeutic mechanism of ECT in the treatment of referactory depression
Acronym Imaging and epigenetic study of ECT
Scientific Title Imaging and epigenetic study for the therapeutic mechanism of ECT in the treatment of referactory depression
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Shigeru Morinobu
Organization Kochi University
Division name Dept. neuropsychiatry, Med. Sch.
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi
TEL 088-880-2359
Email smorinob@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Morinobu
Organization Kochi University
Division name Dept. Neuropsychiatry, Med. Sch.
Zip code
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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 06 Month 09 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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