UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048695 |
|---|---|
| Receipt number | R000055483 |
| Scientific Title | Development of tablet-based neurocognitive tests for patients with schizophrenia. |
| Date of disclosure of the study information | 2022/08/18 |
| Last modified on | 2024/11/29 16:05:45 |
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Basic information
Public title
Development of tablet-based neurocognitive tests for patients with schizophrenia
Acronym
Development of tablet-based neurocognitive tests
Scientific Title
Development of tablet-based neurocognitive tests for patients with schizophrenia.
Scientific Title:Acronym
Development of tablet-based neurocognitive tests
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The cognitive impairment observed in schizophrenia is called Cognitive impairment associated with schizophrenia (CIAS), and has been demonstrated to impair executive function, attention, memory function, processing speed, verbal fluency, and verbal learning. Cognitive impairment can be objectively and quantitatively assessed by performing a test called a neuropsychological test. Because cognitive tests can predict current and future social functioning in schizophrenic patients, tests should be administered to all patients who are in remission of symptoms and have a future plan for social participation. However, because cognitive function tests are "paper-and-pencil" tests, it is difficult to administer them to all patients due to the following points.
1.Requires a trained examiner.
2.A quiet room is necessary.
3.Paper and pencil, testing equipment, etc. are needed.
4.The examiner needs to prepare, clean up, score, and write a report before and after the test.
The purpose of this study is to develop a tablet version of a cognitive function test that can easily assess cognitive dysfunction in schizophrenia. We will develop a testing program that can be performed by patients themselves or with the assistance of assistants such as office staff. The tablet version of the cognitive function test will be made publicly available and widely used in psychiatric clinical practice in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Behavioral performance of tablet version of the cognitive function test to be developed.
Key secondary outcomes
Behavioral performance of the MCCB(MATRICS Consensus Cognitive Battery), an existing cognitive function test
Base
Study type
Observational
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
Patients with schizophrenia
1. patients diagnosed with schizophrenia according to DSM-5 criteria
2. clinically stable patients
3. have the ability to speak Japanese adequately
4. Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Healty participant
1. have the ability to speak Japanese adequately
2. Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
1. Subjects with a history of neurological disease with organic abnormalities in the central nervous system.
2. Subjects with serious cardiovascular, respiratory, gastrointestinal, renal, endocrine, or other diseases, or those with a history of such diseases that the investigator (subinvestigator) determines to be inappropriate as a research subject.
3. Subjects with coexisting diseases related to visual or hearing impairment.
4. Subjects who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsuhito |
| Middle name | |
| Last name | Toyomaki |
Organization
Department of Pychiatry
Division name
Hokkaido University
Zip code
060-8638
Address
Department of Pychiatry
TEL
0117065160
toyomaki@gmail.com
Public contact
Name of contact person
| 1st name | Atsuhito |
| Middle name | |
| Last name | Toyomaki |
Organization
Department of Psychiatry
Division name
Hokkaido university
Zip code
060-8638
Address
Department of Pychiatry
TEL
0117065160
Homepage URL
https://www.psychiatry-hokudai.net/univ/
toyomaki@gmail.com
Sponsor or person
Institute
Hokkaido university
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital, Clinical Research Administration Center
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-716-1161
crjimu@huhp.hokudai.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
| 2022 | Year | 08 | Month | 18 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Behavioral performance of the tablet version of the cognitive function test and existing cognitive function tests.
Management information
Registered date
| 2022 | Year | 08 | Month | 18 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055483
