UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019475
Receipt number R000022525
Scientific Title Neuroimaging and neurophysiological analysis for electroconvulsive therapy (ECT)-related brain structure and function
Date of disclosure of the study information 2015/10/23
Last modified on 2019/10/27 16:46:40

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Basic information

Public title

Neuroimaging and neurophysiological analysis for electroconvulsive therapy (ECT)-related brain structure and function

Acronym

Neuroimaging and neurophysiological analysis for electroconvulsive therapy (ECT)-related brain structure and function

Scientific Title

Neuroimaging and neurophysiological analysis for electroconvulsive therapy (ECT)-related brain structure and function

Scientific Title:Acronym

Neuroimaging and neurophysiological analysis for electroconvulsive therapy (ECT)-related brain structure and function

Region

Japan


Condition

Condition

depression, bipolar disorder, schizophrenia, healthy control

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary purpose of this study is to investigate the effects of ECT on structural and functional network in patients with depression, especially melancholia, bipolar disorder and schizophrenia.
We also explore response predictors for ECT.

Basic objectives2

Others

Basic objectives -Others

The primary purpose of this study is to investigate the effects of ECT on structural and functional network in patients with depression, especially melancholia, bipolar disorder and schizophrenia.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

changes in brain structure (gray matter and white matter) and functional connectivity detected by MRI

Key secondary outcomes

Depressive symptom: Hamilton Depression Rating Scale (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Beck Depression Inventory (BDI)
Manic symptom: Young Mania Rating Scale (YMRS)
Psychomotor disturbance: The CORE Assessment
Psychotic symptom: Brief Psychiatric Rating Scale (BPRS), Positive and Negative Syndrome Scale (PANSS)
Psychotic Depression Assessment Scale (PDAS)
Catatonic symptom: Bush-Francis Catatonia Rating Scale (BFCRS)
Clinical Global Impression (CGI)
Global Assessment of Functioning (GAF)
Cognitive function: Mini-Mental State Examination (MMSE)
QOL: EuroQOL

EEG


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

<Major depressive disorder or bipolar disorder>
1. Inpatients in our hospital with diagnosis of bipolar I/II disorder, major depressive disorder
2. clinical indications for ECT (indication and informed consent for ECT treatment already obtained before recruitment independently of the study.)

<Schizophrenia>
1. Inpatients in our hospital with a diagnosis of schizophrenia or schizoaffective disorder
2. clinical indications for ECT (indication and informed consent for ECT treatment already obtained before recruitment independently of the study.)

Key exclusion criteria

1. Another major psychiatric illness
2. Current drug or alcohol dependence
3. Neurological or degenerative disorders (e.g. epilepsy, Alzheimer)
4. Unstable or severe medical illness (e.g. myocardial infarction within 1 month)
5. Pregnancy
6. ECT treatment within the last 3 months
7. Patients who cannot participate in the MRI scanning because of contraindications to MRI (e.g. pacemaker)
8. patients with mandatory admission by mayor of municipality

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Takamiya

Organization

Komagino Hospital

Division name

Psychiatry

Zip code

1938505

Address

273 Uratakaomachi Hachioji-shi Tokyo

TEL

042-663-2222

Email

akihiro.takamiya@gmail.com


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Takamiya

Organization

Komagino Hospital

Division name

Psychiatry

Zip code

1938505

Address

273 Uratakaomachi Hachioji-shi Tokyo

TEL

042-663-2222

Homepage URL


Email

akihiro.takamiya@gmail.com


Sponsor or person

Institute

Komagino Hospital

Institute

Department

Personal name



Funding Source

Organization

Komagino Hospital, Inokashira Hspital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Komagino Hospital IRB

Address

273 Uratakaomachi Hachioji-shi Tokyo

Tel

042-663-2222

Email

norimura@komagino.jp


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

2015 Year 10 Month 23 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

2015 Year 10 Month 10 Day

Date of IRB

2015 Year 10 Month 23 Day

Anticipated trial start date

2015 Year 10 Month 24 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is prospective and observational.
Participants have already been indicated for ECT in our hospital independently of this study between October 2015 and March 2021 (all participants will receive standard ECT treatments in clinical settings provided by their attending physicians. The informed consent for ECT treatment have already been obtained before recruitment independently of the study).
Participants are required to meet the inclusion criteria (1. Inpatients in our hospital, a diagnosis of either schizophrenia, schizoaffective disorder, bipolar I/II disorder or major depressive disorder. 2. clinical indications for ECT (indication and informed consent for ECT treatment already obtained before recruitment independently of the study.)) and are required not to meet the exclusion criteria (1. Another major psychiatric illness 2. Current drug or alcohol dependence 3. Neurological or degenerative disorders (e.g. epilepsy, Alzheimer) 4. Unstable or severe medical illness (e.g. myocardial infarction within 1 month) 5. Pregnancy 6. ECT treatment within the last 3 months 7. Patients who cannot participate in the MRI scanning because of contraindications to MRI (e.g. pacemaker) 8. patients with mandatory admission by mayor of municipality).

Participants will undergo MRI and EEG before and 1 week after, and 3 months after the course of ECT.
For control group, we will include age- and gender-matched healthy controls who have never received ECT.

We will apply the diagnostic criteria for "melancholia" described by Hyett (Hyett et al., 2015), and use SMPI, as well as the specifier (with melancholic features) based on DSM and we will divide "melancholia" and "non-melancholia" for patients with bipolar I/II disorder or major depressive disorder.


Management information

Registered date

2015 Year 10 Month 23 Day

Last modified on

2019 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022525


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name