UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037740 |
|---|---|
| Receipt number | R000043044 |
| Scientific Title | Study on long-term improvement effect of cognitive function in schizophrenic patients by cognitive rehabilitation |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2019/08/20 12:19:12 |
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Basic information
Public title
Study on long-term improvement effect of cognitive function in schizophrenic patients by cognitive rehabilitation
Acronym
Long-term improvement effect of cognitive rehabilitation
Scientific Title
Study on long-term improvement effect of cognitive function in schizophrenic patients by cognitive rehabilitation
Scientific Title:Acronym
Long-term improvement effect of cognitive rehabilitation
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the long-term effects of cognitive rehabilitation (NEAR) on patients diagnosed with schizophrenia or schizophrenia emotional disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
BACS-J
Key secondary outcomes
SWNS,SECL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
NEAR
Interventions/Control_2
Normal day care treatment only
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
| 14 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those diagnosed with schizophrenia or schizophrenia emotional disorder according to DSM5 diagnostic criteria
2) Those aged 13 to 65 years (according to NEAR Implementation Manual 4)
3) Patients who have received normal treatment and NEAR or normal treatment only in DC, and have passed BACS for more than 6 months
4) A person who has received sufficient explanation for participation in the study and has obtained written consent based on the patient's free will
Key exclusion criteria
1) Those whose medical condition is unstable and it is difficult to conduct a follow-up survey
2) Persons with intellectual disability, alcohol / drug dependence, dementia, epilepsy, etc.
3) Persons who are judged to be ineligible by the attending physician or the research supervisor
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Shinshu University School of Medicine
Division name
School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto City
TEL
0263-37-2403
mkobaya@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Iwane |
Organization
Kyoto Prefectural Shonan Hospital
Division name
Rehabilitation center
Zip code
611-0011
Address
2 Gokasho Hirookadani, Uji City
TEL
0774-32-5900
Homepage URL
t-iwane4649@rakunan-hosp.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural Shonan Hospital
Address
2 Gokasho Hirookadani, Uji City
Tel
0774-32-5900
t-iwane4649@rakunan-hosp.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 | 03 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 20 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043044
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
