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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035847
Receipt No. R000040804
Scientific Title Neurophysiological research on the mechanism of emotion regulation : EEG/MEG study
Date of disclosure of the study information 2019/02/14
Last modified on 2019/02/12

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Basic information
Public title Neurophysiological research on the mechanism of emotion regulation : EEG/MEG study
Acronym Neurophysiological research on the mechanism of emotion regulation : EEG/MEG study
Scientific Title Neurophysiological research on the mechanism of emotion regulation : EEG/MEG study
Scientific Title:Acronym Neurophysiological research on the mechanism of emotion regulation : EEG/MEG study
Region
Japan

Condition
Condition Schizophrenia
Bipolar disorder
Major depressive disorder
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to examine physiological responses of the brain relate to emotion regulation during emotional stimulation by EEG/MEG and to find its neurophysiological characteristics.
Basic objectives2 Others
Basic objectives -Others To examine neurophysiological responses to emotion regulation during neutral and aversive stimuli in patients with schizophrenia, bipolar disorder and major depressive disorder using EEG/MEG.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frontal induced gamma band power
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Schizophrenia
Bipolar Disorder
Major Depression
Normal Control

Run the same experiment for all
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
65 years-old >=
Gender Male and Female
Key inclusion criteria [Patients]
1. Men and women aged 20 to 65
2. Patients with Schizophrenic / Bipolar disorder / Major depressive disorder.
3. Diagnosis is by DSM-V
4. Diagnosis is performed by two or more psychiatrists, and if both diagnoses are different, they are excluded

[HealthyControl]
1. Men and women aged 20 to 65
Key exclusion criteria [Patients]
1. History of concussion or severe head injury
2. History of neurological disorder
2. History of electroconvulsive therapy
4. Alcohol dependence or drug dependence
5. Alcohol dependence or drug dependence in 5 years
6. Linguistic IQ is less than 75
7. Irreparable dysopia
8. When researcher determines that it is ineligible

[HealthyControl]
1. History of concussion or severe head injury
2. History of neurological disorder
3. History of mental disorder in the first-degree family based on the information of the principal
4. History of use of a psychotropic medicine (mood stabilizer, antipsychotic medicine, etc.)
5. Linguistic IQ is less than 75
6. Irreparable dysopia
7. When researcher determines that it is ineligible
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kanba Shigenobu
Organization Kyushu University
Division name Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
TEL 092-642-5641
Email nouseiri.ku@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Onitsuka Toshiaki
Organization Kyushu University
Division name Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
TEL 092-642-5641
Homepage URL
Email nouseiri.ku@gmail.com

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 14 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 04 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
2019 Year 02 Month 12 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040804

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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