UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023198
Receipt number 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 15:01:14

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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 or person

Institute

Department of Neuropsychiatry, Kochi Medical School, Kochi University

Institute

Department

Personal name



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

Value
https://center6.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