UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023004 |
|---|---|
| Receipt number | R000026516 |
| Scientific Title | Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder patients. |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2020/06/02 14:05:30 |
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Basic information
Public title
Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder patients.
Acronym
Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder patients.
Scientific Title
Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder patients.
Scientific Title:Acronym
Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder patients.
Region
| Japan |
Condition
Condition
schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brief Assessment of Cognition in Schizophrenia: BACS, Self Efficacy for Community Life scale: SECL, Life Assessment Scale for Mental Ill: LASMI, and The Global Assessment of Functioning Scale: GAF after cognitive rehabilitation for 6 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
cognitive rehabilitation
Interventions/Control_2
twice a week, 6 months
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
schizophrenia, major depressive disorder, bipolar disorder, neurodevelopmental disorder patinets
intelligence quotient more than 70 by Wechsler Adult Intelligence Scale- Third Edition, all z score of subscale of Brief Assessment of Cognition in Schizophrenia more than -2
Key exclusion criteria
nothing in particular
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kitamura |
Organization
Kawasaki medical school
Division name
Depatment of Psychiatry
Zip code
701-0192
Address
577, Matsushima, Kurashiki-city, Okayama 701-0192, Japan
TEL
086-462-1111
n-kitamura@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Kitamura |
Organization
Kawasaki medical school
Division name
Depatment of Psychiatry
Zip code
701-0192
Address
577, Matsushima, Kurashiki-city, Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
n-kitamura@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki medical school department psychiatry
Institute
Department
Personal name
Funding Source
Organization
Kawasaki medical school department psychiatry
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
Research ethics committee of Kawasaki Medical School and Kawasaki Medical School Hospital
Address
577, Matsushima, Kurashiki-city, Okayama 701-0192, Japan
Tel
086-462-1111
kmsres@med.kawasaki-m.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
| 2016 | Year | 08 | 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
6
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
due to termination of this research
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
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 04 | Day |
Last modified on
| 2020 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026516
| 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 |
