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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040030
Receipt No. R000045634
Scientific Title Behavioral and neurophysiological research on perceptual processing of speech and musical information in psychiatric patients.
Date of disclosure of the study information 2020/04/02
Last modified on 2020/04/02

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Basic information
Public title Behavioral and neurophysiological research on perceptual processing of speech and musical information in psychiatric patients.
Acronym Behavioral and neurophysiological research on speech and music perception in psychiatric patients.
Scientific Title Behavioral and neurophysiological research on perceptual processing of speech and musical information in psychiatric patients.
Scientific Title:Acronym Behavioral and neurophysiological research on speech and music perception in psychiatric patients.
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to examine neural oscillations related to speech and music perception by EEG/MEG in psychiatric disorders (schizophrenia, bipolar disorder, major depressive disorder).
Basic objectives2 Others
Basic objectives -Others The objective of this study is to examine neural oscillations related to speech and music perception by EEG/MEG in psychiatric disorders (schizophrenia, bipolar disorder, major depressive disorder) and find potential biomarkers of these disorders.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Power of theta and gamma band neural oscillations
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
15 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria [Patients]
1. Men and women aged 15 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 15 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 Toshiaki
Middle name
Last name Onitsuka
Organization Kyushu University
Division name Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code 812-8582
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 Toshiaki
Middle name
Last name Onitsuka
Organization Kyushu University
Division name Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code 812-8582
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 Kyushu University
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
Tel 092-642-5082
Email byskenkyu@jimu.kyushu-u.ac.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
2020 Year 04 Month 02 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
2020 Year 04 Month 01 Day
Date of IRB
2020 Year 04 Month 01 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 02 Day
Last modified on
2020 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045634

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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