UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008818 |
|---|---|
| Receipt number | R000010362 |
| Scientific Title | Effect of cognitive rehabilitation for schizophrenia patients on cognitive function and brain structures |
| Date of disclosure of the study information | 2012/09/07 |
| Last modified on | 2021/09/08 19:02:43 |
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Basic information
Public title
Effect of cognitive rehabilitation for schizophrenia patients on cognitive function and brain structures
Acronym
Effect of cognitive rehabilitation for schizophrenia patients
Scientific Title
Effect of cognitive rehabilitation for schizophrenia patients on cognitive function and brain structures
Scientific Title:Acronym
Effect of cognitive rehabilitation for schizophrenia patients
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of cognitive rehabilitation on schizophrenic patients' cognitive function and brain structures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
BACS-J
Trail making test
Stroop test
Raven's matrices test
Visual memory/working memory(WMS-R)
Arithmetics(WAIS-III)
Brain structures measured by MRI
Key secondary outcomes
Positive and Negative Syndrome Scale
WHO Quality of Life 26
Schizophrenia Cognition Rating Scale
Social Functioning Scale
Brief Core Schema Scale
Beck Cognitive Insight Scale
Rosenberg Self-Esteem Scale
Beck Depression Inventory-II
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Cognitive training at home using cognitive training games (4 times a week, for 8 weeks)
Interventions/Control_2
Playing videogames (visuospatial puzzle games) at home (4 times a week, for 8weeks)
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with schizophrenia
No admission in last 8 weeks
No plan to change anti-psychotic drugs
Key exclusion criteria
Estimated IQ lower than 80 (by Japanese Adult Reading Test)
History of organic brain disorder, neurological disorder, or substance/alcohol dependence
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Matsuoka |
Organization
Tohoku University
Division name
Department of Psychiatry
Zip code
9808575
Address
2-1, Seiryo-chou, Aoba-ku, Sendai-shi
TEL
022-717-7262
idee@diana.dti.ne.jp
Public contact
Name of contact person
| 1st name | Kunio |
| Middle name | |
| Last name | Iizuka |
Organization
Tohoku University
Division name
Department of Psychiatry
Zip code
9808575
Address
2-1, Seiryo-chou, Aoba-ku, Sendai-shi
TEL
022-717-7262
Homepage URL
idee@diana.dti.ne.jp
Sponsor or person
Institute
Tohoku University, Department of Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1, Seiryo-chou, Aoba-ku, Sendai-shi
Tel
022-717-8006
med-kenkyo@grp.tohoku.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 07 | 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
32
Results
.
Results date posted
| 2021 | Year | 09 | Month | 08 | 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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 31 | Day |
Last modified on
| 2021 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010362
