UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031518 |
|---|---|
| Receipt number | R000035974 |
| Scientific Title | Basic research on self-regulation of delusive perception by N400-biofeedback in schizophrenia |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/03/25 14:19:02 |
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Basic information
Public title
Basic research on self-regulation of delusive perception by N400-biofeedback in schizophrenia
Acronym
Basic research on self-regulation of delusive perception by N400-biofeedback in schizophrenia
Scientific Title
Basic research on self-regulation of delusive perception by N400-biofeedback in schizophrenia
Scientific Title:Acronym
Basic research on self-regulation of delusive perception by N400-biofeedback in schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia Spectrum Disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify the correlation between N400 event-related potential and delusive perception on healthy control and schizophrenia spectrum disorders in order to develop a new method of self-control delusions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate correlation between delusive perception and N400 using psychological assessments, N400 amplitude and latency.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
For healthy control
(1) Aged 20-65 years old
For patients
(1) Aged 20-65 years old
(2) Being diagnosed as schizophrenia spectrum disorder according to DSM-V
(3) Meet the criteria of schizophrenia on SCID-I
Key exclusion criteria
For healthy control
(1) Meet the criteria of any psychiatric disorders on SCID-I/II
(2) History of mental illness
(3) History of mental illness on first-degree relatives
(4) History of cranial nerve disease and/or cerebral vascular diseases
(5) Having visual and/or hearing diseases
(6) History of illegal drug use
For patients
(1) History of cranial nerve disease and/or cerebral vascular diseases
(2) Having visual and/or hearing diseases
(3) Having a neurocognitive disorder
(4) History of illegal drug use
(5) Having a Substance-related and addictive disorders
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanao Yamamura |
Organization
Kanazawa University Hospital
Division name
Neuropsychiatry
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa, 920-8640, Japan
TEL
076-265-2307
yamamuratak@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanao Yamamura |
Organization
Kanazawa University Hospital
Division name
Neuropsychiatry
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa, 920-8640, Japan
TEL
076-265-2307
Homepage URL
yamamuratak@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
0
Results
The research was discontinued due to the retirement of the researcher.
Results date posted
| 2019 | Year | 03 | Month | 25 | Day |
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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Procedure
Healthy control:
We recruit 30 healthy control volunteers through a homepage and mailing-list from January 17, 2018. We obtain written informed consent using a document with the approval of the ethics committee. We conduct psychological test and EEG (N400) experiment in Kanazawa University hospital. We calculate earson correlation coefficient between N400 amplitude/latency and delusive thought score to show validation of this experiment.
Patients:
After showing validation of this experiment, we recruit 30 schizophrenia out/inpatient in Kanazawa University hospital diagnosed by physicians. We obtain written informed consent using a document with the approval of the ethics committee. We conducted EEG (N400) experiment by the same procedure of the healthy control group.
Management information
Registered date
| 2018 | Year | 02 | Month | 28 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035974
| Research Plan | |
|---|---|
| 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 |
