UMIN-CTR Clinical Trial

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
Institute	Komagino Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022525