UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009788 |
|---|---|
| Receipt number | R000011463 |
| Scientific Title | Development of an assessment tool and cognitive rehabilitation strategy for working memory impairment in schizophrenia |
| Date of disclosure of the study information | 2013/01/21 |
| Last modified on | 2018/07/22 10:42:52 |
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Basic information
Public title
Development of an assessment tool and cognitive rehabilitation strategy for working memory impairment in schizophrenia
Acronym
Assessment and cognitive rehabilitation for working memory impairment in schizophrenia
Scientific Title
Development of an assessment tool and cognitive rehabilitation strategy for working memory impairment in schizophrenia
Scientific Title:Acronym
Assessment and cognitive rehabilitation for working memory impairment in schizophrenia
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a cognitive rehabilitation strategy for working memory impairment in schizophrenia assessed using fMRI
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain activation and behavioral parameters using new delayed response task focused on central executive system along with verbal N-back task and non-verbal N-back task
PANSS
BACS
CSB
JART-25
Key secondary outcomes
UPSA-B
SFS
SLOF
SF36
FEIT-J
Hinting task
SCSQ
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Cognitive training focused on working memory consisting of two 45 min computer sessions (computer soft) and a 45 min verbal session (group meeting) per week during 12 weeks
Interventions/Control_2
Cognitive training (NEAR) treating a broad range of cognition consisting of two 45 min computer sessions (computer soft) and a 45 min verbal session (group meeting) per week during 12 weeks
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Forty-five patients with schizophrenia according to the DSM-IV criteria recruited from outpatients and inpatients of National Center Hospital, National Center of Neurology and Psychiatry (NCNP). All patients were 20-60 years old and had the capacity to give written informed consent.
Key exclusion criteria
(1)Patients with the estimated IQ lower than 80 (by Japanese Adult Reading Test)
(2)Patients with history of organic brain disorder, dementia, pervasive developmental disorder, or substance/alcohol dependence.
(3)Patients with severe irritation that hindered them from being seated still during the experiment.
(4)Patients for whom changes in medication were presumed to be necessary during the study
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Nakagome |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health
Zip code
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
nakagome@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Takeda |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Psychiatry
Zip code
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
ktakeda@ncnp.go.jp
Sponsor or person
Institute
National Center Hospital, National Center of Neurology and 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
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
国立精神・神経医療研究センター病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pre-training data of this intervention study would partly include the data obtained in an observational study in search for new assessment method of working memory impairment in schizophrenia.
Management information
Registered date
| 2013 | Year | 01 | Month | 16 | Day |
Last modified on
| 2018 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011463
