UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050008 |
|---|---|
| Receipt number | R000056901 |
| Scientific Title | Elucidating the pathophysiology of schizophrenia by measuring "prediction error" using magnetoencephalography. |
| Date of disclosure of the study information | 2023/01/11 |
| Last modified on | 2023/03/16 18:13:12 |
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Basic information
Public title
Elucidating the pathophysiology of schizophrenia by measuring "prediction error" using magnetoencephalography.
Acronym
Elucidating the pathophysiology of schizophrenia by measuring "prediction error" using magnetoencephalography.
Scientific Title
Elucidating the pathophysiology of schizophrenia by measuring "prediction error" using magnetoencephalography.
Scientific Title:Acronym
Elucidating the pathophysiology of schizophrenia by measuring "prediction error" using magnetoencephalography.
Region
| Japan |
Condition
Condition
schizophrenia and healthy control
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the function of face recognition in schizophrenia from the perspective of brain predictability using magnetoencephalography.
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Power values for each brain region and connectivity between regions during masked face recognition task
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
Head MRI, magnetoencephalography on task
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects group
(1) Adult males and females
Patient group
(1) Adult males and females
(2) Patients with schizophrenia
(3) Diagnosis will be conducted based on DSM-5
Key exclusion criteria
Healthy subjects group
(1) Subjects with a history of psychiatric or neurological disorders
(2) Subjects with contraindications to MRI and magnetoencephalography (e.g., implanted cardiac pacemaker, fear of claustrophobia, etc.)
(3) Subjects with serious physical illnesses.
Patient group
(1) Subjects who are hospitalized
(2) Subjects with contraindications to MRI and magnetoencephalography (e.g., implanted cardiac pacemaker, fear of claustrophobia, etc.)
(3) Subjects with serious physical illness
(4) When the researcher judges that the subject is unsuitable for the study due to unstable symptoms, etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Fukuda |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi City, Gunma
TEL
027-220-8190
tyuichi@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Takei |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi City, Gunma
TEL
027-220-8190
Homepage URL
tyuichi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
No research funding source
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
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi City, Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
群馬大学医学部附属病院（群馬県）、群馬県立精神医療センター（群馬県）、つつじメンタルクリニック（群馬県）、城西クリニック（群馬県）、熊谷総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 11 | 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
| 2022 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional analytical observational study. The subjects will be schizophrenic patients and healthy subjects attending Gunma University Hospital, Kumagaya General Hospital, Tsutsuji Mental Hospital, and Gunma Prefectural Psychiatric Center as outpatients. Posters inviting healthy subjects to participate in the study will be prepared and displayed at Gunma University and at the collaborating institutions to recruit them. The participants will be asked to perform a computerized masked face recognition task while magnetoencephalography (MEG) measurements are performed. The task is to generate event-related potentials due to prediction error by presenting an image of a masked face followed by an image of an unmasked face, and it takes about 15 minutes. The task is created using the stimulus presentation software PsychoPy. Psychological testing will be conducted to assess psychiatric symptoms. The acquired data will be statistically compared between normal subjects and schizophrenic subjects, and correlated with the rating scale of psychiatric symptoms.
Adult patients with schizophrenia and healthy subjects (adults with no current or past psychiatric or neurological disorders) who are outpatients at the above facility between March 14, 2023 and March 31, 2026 will be included in the study. The target number of cases will be 100 schizophrenic patients and 100 healthy subjects. Minors, patients with contraindications to MRI and magnetoencephalography such as implanted cardiac pacemakers or claustrophobia, patients with serious physical illnesses (similar to the patients who are eligible for the additional fee for management of psychiatric complications), hospitalized patients, and patients whose psychiatric symptoms are unstable or whose physicians deem them unsuitable for the study will be excluded from the The research subjects will be excluded from the study.
Management information
Registered date
| 2023 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056901
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
