UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039521 |
|---|---|
| Receipt number | R000045042 |
| Scientific Title | Cognitive training for schizophrenia: a randomized controlled trial |
| Date of disclosure of the study information | 2020/02/18 |
| Last modified on | 2021/03/11 12:12:17 |
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Basic information
Public title
Cognitive training for schizophrenia: a randomized controlled trial
Acronym
Cognitive training for schizophrenia: a randomized controlled trial
Scientific Title
Cognitive training for schizophrenia: a randomized controlled trial
Scientific Title:Acronym
Cognitive training for schizophrenia: a randomized controlled trial
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of cognitive training for schizophrenia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brief Assessment of Cognition in Schizophrenia (BACS)
Key secondary outcomes
Schizophrenia Cognition Rating Scale (SCoRS)
Intrinsic motivation inventory (IMI)
Quality of Life Scale (QLS)
Positive and Negative Syndrome Scale (PANSS)
Scale for the Assessment of Negative Symptoms (SANS)
Global Assessment of Functioning (GAF)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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 training. 12 weeks, 2 computer and 1 group meeting sessions/week.
Interventions/Control_2
Treatment as usual
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
schizophrenia or schizoaffective disorder based on DSM-5
Key exclusion criteria
mental retardation; alcohol or drug dependence; history of neurological disorders
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Shinshu University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
396-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2403
mkobaya@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Yamanushi |
Organization
Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Division name
Department of Rehabilitation
Zip code
386-0401
Address
3057-1, Shiogawa, Ueda, Nagano, Japan
TEL
0268-35-0305
Homepage URL
ot@seitaikai.or.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-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
医療法人清泰会メンタルサポートそよかぜ病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 18 | 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
| 2020 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 02 | Month | 18 | Day |
Last modified on
| 2021 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045042
