Unique ID issued by UMIN | UMIN000019475 |
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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 |
Neuroimaging and neurophysiological analysis for electroconvulsive therapy (ECT)-related brain structure and function
Neuroimaging and neurophysiological analysis for electroconvulsive therapy (ECT)-related brain structure and function
Neuroimaging and neurophysiological analysis for electroconvulsive therapy (ECT)-related brain structure and function
Neuroimaging and neurophysiological analysis for electroconvulsive therapy (ECT)-related brain structure and function
Japan |
depression, bipolar disorder, schizophrenia, healthy control
Psychiatry |
Others
NO
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.
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.
Exploratory
Pragmatic
changes in brain structure (gray matter and white matter) and functional connectivity detected by MRI
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
<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.)
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
120
1st name | Akihiro |
Middle name | |
Last name | Takamiya |
Komagino Hospital
Psychiatry
1938505
273 Uratakaomachi Hachioji-shi Tokyo
042-663-2222
akihiro.takamiya@gmail.com
1st name | Akihiro |
Middle name | |
Last name | Takamiya |
Komagino Hospital
Psychiatry
1938505
273 Uratakaomachi Hachioji-shi Tokyo
042-663-2222
akihiro.takamiya@gmail.com
Komagino Hospital
Komagino Hospital, Inokashira Hspital
Other
Komagino Hospital IRB
273 Uratakaomachi Hachioji-shi Tokyo
042-663-2222
norimura@komagino.jp
NO
2015 | Year | 10 | Month | 23 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 10 | Month | 10 | Day |
2015 | Year | 10 | Month | 23 | Day |
2015 | Year | 10 | Month | 24 | Day |
2021 | Year | 03 | Month | 31 | Day |
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.
2015 | Year | 10 | Month | 23 | Day |
2019 | Year | 10 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022525
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