UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046782 |
|---|---|
| Receipt number | R000053368 |
| Scientific Title | Visual Attention Impairment in Patients with Schizophrenia and Mood Disorder |
| Date of disclosure of the study information | 2022/01/31 |
| Last modified on | 2022/01/31 10:58:47 |
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Basic information
Public title
Visual Attention Impairment in Psychiatric Disorder
Acronym
Visual Attention Impairment Study
Scientific Title
Visual Attention Impairment in Patients with Schizophrenia and Mood Disorder
Scientific Title:Acronym
Visual Attention Impairment Study
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 relationship between abnormal visual attention and impaired decision-making in patients with schizophrenia and mood disorders will be investigated objectively and non-invasively in a short time by means of preference responses to food images, and the physiological responses of the brain will be examined by means of EEG differences.
Basic objectives2
Others
Basic objectives -Others
In this study, we will present food images to subjects and ask them to make absolute or relative judgments about their image preferences. We will use a gaze tracking device to investigate the focus of attention in the patient's decision-making process and the characteristics of the decision-making process, and simultaneously acquire EEG data. We will conduct exploratory analyses based on the obtained data, and aim to apply them to devices for diagnosis and condition assessment in the future.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Image presentation time and actual image gazing time according to the preference level.
Frequency of event-related potentials during image presentation and during preference selection.
Key secondary outcomes
Correlation coefficients of image presentation time and image gaze time with symptoms and cognitive functions.
Frequency of event-related potentials during image presentation and preference selection.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
Perform 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Patients]
(1) Males and females aged 18 to 65
(2) Patients with schizophrenia, bipolar disorder, or major depressive disorder
(3) Diagnosis will be made by two or more psychiatrists, and if the two diagnoses differ, the patient will be excluded.
[Healthy subjects]
(1) Males and females aged 18 to 65 years
Key exclusion criteria
[Patients]
(1) History of concussion or severe head trauma
(2) History of neurological disease
(3) History of electroconvulsive therapy
(4) Alcohol or drug dependence
(5) History of alcohol or drug abuse within the past 5 years
(6) Uncorrectable visual impairment
(7) When the researcher judges that the subject is ineligible.
[Healthy subjects]
(1) History of concussion or severe head trauma
(2) History of neurological or psychiatric disorders
(3) History of psychiatric disease in a first-degree relative based on the patient's information
(4) History of psychotropic drug use.
(5) Uncorrectable visual impairment.
(6) When the researcher is judged to be 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
092-642-5627
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
092-642-5627
Homepage URL
nouseiri.ku@gmail.com
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
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
092-642-5627
nouseiri.ku@gmail.com
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
| 2022 | Year | 01 | Month | 31 | 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 | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 31 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053368
