UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026146 |
|---|---|
| Receipt number | R000030051 |
| Scientific Title | Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for patients with schizophrenia. |
| Date of disclosure of the study information | 2017/02/15 |
| Last modified on | 2019/06/20 10:10:42 |
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Basic information
Public title
Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for patients with schizophrenia.
Acronym
Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for patients with schizophrenia.
Scientific Title
Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for patients with schizophrenia.
Scientific Title:Acronym
Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for patients with schizophrenia.
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to examine whether a cognitive remediation program including both computerised cognitive training using Jcores and therapist intervention for transferring gained cognitive improvement into a real-world setting is more effective than treatment as usual.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the Brief Assessment of Cognition in Schizophrenia
Key secondary outcomes
Positive and Negative Syndrome Scale
Life Assessment Scale for Mentally Ill
NIRS
MRI
serum BDNF, proBDNF, MMP9
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
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
| Behavior,custom |
Interventions/Control_1
a cognitive remediation programme with original computerised cognitive training and group meeting
Interventions/Control_2
Participants engaged in two computerised cognitive training sessions and one group meeting per week for 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
Participants were outpatients diagnosed with Schizophrenia by psychiatrists according to DSM-5 criteria.
Key exclusion criteria
mental retardation
history of drug or alcohol abuse
organic central nervous system disorder
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Matsuda |
Organization
Nara Medical University School of Medicine
Division name
Department of Psychiatry
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara 634-8523, Japan
TEL
0744-22-3051
yasumatsuda319@hotmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Matsuda |
Organization
Nara Medical University School of Medicine
Division name
Department of Psychiatry
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara 634-8523, Japan
TEL
0744-22-3051
Homepage URL
yasumatsuda319@hotmail.com
Sponsor or person
Institute
Nara Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University School of Medicine
Address
840 Shijo-cho, Kashihara, Nara 634-8523, Japan
Tel
0744-22-3051
smuraka@naramed-u.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
奈良県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
62
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
Main results already published
Date of protocol fixation
| 2013 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 15 | Day |
Last modified on
| 2019 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030051
