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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032806
Receipt No. R000037423
Scientific Title The effect of compensatory cognitive training for patients with schizophrenia
Date of disclosure of the study information 2018/06/01
Last modified on 2019/04/12

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Basic information
Public title The effect of compensatory cognitive training for patients with schizophrenia
Acronym The effect of compensatory cognitive training for patients with schizophrenia
Scientific Title The effect of compensatory cognitive training for patients with schizophrenia
Scientific Title:Acronym The effect of compensatory cognitive training for patients with schizophrenia
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of Cognitive Remediation Therapy (CRT) focusing on the cognitive function problem in schizophrenia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neuropsychological tests, clinical symptom measures, NIRS and BDNF at pre and post intervention
Key secondary outcomes Neuropsychological tests, clinical symptom measures, NIRS and BDNF at 3 months after intervention

Base
Study type Interventional

Study design
Basic design Parallel
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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 CRT, once a week for 3 months
Interventions/Control_2 Non-CRT
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient who meets ICD-10 criteria for schizophrenia
2) Patients whose condition is relatively stable
3) Patient who gave written informed consent
Key exclusion criteria 1) dependence on alcohol
2) Patients who are at high risk of violence, suicide attempts, impulsive acts
3) Patients with head trauma, cerebrovascular disorders and neurodegenerative diseases
4) Patients under 16 years of age
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yuko
Middle name
Last name Higuchi
Organization University of Toyama
Division name Department of Neuropsychiatry
Zip code 930-0152
Address 2630 Sugitani, Toyama
TEL 076-434-7323
Email yhiguchi@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name Shotaro
Middle name
Last name Nakada
Organization University of Toyama
Division name Department of Neuropsychiatry
Zip code 930-0152
Address 2630 Sugitani, Toyama
TEL 076-434-7323
Homepage URL
Email noutore_toyama@yahoo.co.jp

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toyama university hospital Center for Clinical Research
Address 2630 Sugitani, Toyama
Tel 076-415-8857
Email rinri@adm.u-toyama.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 富山大学附属病院(富山県)、砺波サナトリウム福井病院(富山県)

Other administrative information
Date of disclosure of the study information
2018 Year 06 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 41
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 Completed
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2017 Year 10 Month 10 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2019 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
2018 Year 05 Month 31 Day
Last modified on
2019 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037423

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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