UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044805 |
|---|---|
| Receipt number | R000051172 |
| Scientific Title | Clinical EEG studies of spontaneous EEG and auditory steady-state responses in schizophrenia, mood disorders, autism spectrum disorders, epilepsy, and healthy control |
| Date of disclosure of the study information | 2021/07/12 |
| Last modified on | 2021/07/08 23:08:29 |
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Basic information
Public title
Clinical EEG studies of spontaneous EEG and auditory steady-state responses in schizophrenia, mood disorders, autism spectrum disorders, epilepsy, and healthy control
Acronym
Clinical EEG research for psychiatric disorders
Scientific Title
Clinical EEG studies of spontaneous EEG and auditory steady-state responses in schizophrenia, mood disorders, autism spectrum disorders, epilepsy, and healthy control
Scientific Title:Acronym
Clinical EEG research for psychiatric disorders
Region
| Japan |
Condition
Condition
schizophrenia, mood disorders, autism spectrum disorders, epilepsy, and healthy control
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to detect neurophysiological biomarkers for various psychiatric disorders, such as schizophrenia, mood disorder, autism spectrum disorder, and epilepsy by analyzing spontaneous EEG activity and auditory steady-state response.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Power spectral density for each EEG electrode and coherence between electrodes
Key secondary outcomes
Gamma-band power and phase locking factor for each EEG electrode in auditory steady-state response
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
spontaneous activity, auditory steady-state response
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
Healthy subjects group
(1) Males and females aged 20-65 years
Patient group
(1) Males and females aged 20-65 years
(2) Patients with schizophrenia, bipolar disorder, major depressive disorder, and autism spectrum disorder
(3) Diagnosis will be conducted based on DSM-V
(4) Two or more psychiatrists will conduct a diagnosis of each patient
Key exclusion criteria
Normal group
(1) History of neurological disease or severe head injury
(2) History of electroconvulsive therapy
(3) History of alcohol or drug abuse within the past 5 years
(4) When the participant is suspected of having a mental illness in a structured interview (SCID non-patient edition), or, when a first-degree close relative (parent, sibling, child) has a mental illness
(5) Hearing impairment
Patient group
(1) History of Neurological disorders (excluding epilepsy in the epilepsy group) or severe head trauma
(2) History of electroconvulsive therapy
(3) History of alcohol abuse or drug abuse within the past 5 years
(4) Hearing impairment
(5) When researcher judge that the patient is ineligible to participate this study
Target sample size
1050
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Onitsuka |
Organization
Kyushu University
Division name
Department of Neuroimaging Psychiatry, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
TEL
092-642-5641
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 Neuroimaging Psychiatry, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
TEL
092-642-5641
Homepage URL
nouseiri.ku@gmail.com
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency of Medical Research and Development
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
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
| 2021 | Year | 07 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 06 | 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
| 2021 | Year | 07 | Month | 08 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051172
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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