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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008818
Receipt No. R000010362
Scientific Title Effect of cognitive rehabilitation for schizophrenia patients on cognitive function and brain structures
Date of disclosure of the study information 2012/09/07
Last modified on 2017/03/06

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Basic information
Public title Effect of cognitive rehabilitation for schizophrenia patients on cognitive function and brain structures
Acronym Effect of cognitive rehabilitation for schizophrenia patients
Scientific Title Effect of cognitive rehabilitation for schizophrenia patients on cognitive function and brain structures
Scientific Title:Acronym Effect of cognitive rehabilitation for schizophrenia patients
Region
Japan

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

Objectives
Narrative objectives1 To assess the effect of cognitive rehabilitation on schizophrenic patients' cognitive function and brain structures.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes BACS-J
Trail making test
Stroop test
Raven's matrices test
Visual memory/working memory(WMS-R)
Arithmetics(WAIS-III)
Brain structures measured by MRI
Key secondary outcomes Positive and Negative Syndrome Scale
WHO Quality of Life 26
Schizophrenia Cognition Rating Scale
Social Functioning Scale
Brief Core Schema Scale
Beck Cognitive Insight Scale
Rosenberg Self-Esteem Scale
Beck Depression Inventory-II

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Cognitive training at home using cognitive training games (4 times a week, for 8 weeks)
Interventions/Control_2 Playing videogames (visuospatial puzzle games) at home (4 times a week, for 8weeks)
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
40 years-old >
Gender Male and Female
Key inclusion criteria Patients with schizophrenia
No admission in last 8 weeks
No plan to change anti-psychotic drugs
Key exclusion criteria Estimated IQ lower than 80 (by Japanese Adult Reading Test)
History of organic brain disorder, neurological disorder, or substance/alcohol dependence
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroo Matsuoka
Organization Tohoku University
Division name Department of Psychiatry
Zip code
Address 2-1, Seiryo-chou, Aoba-ku, Sendai-shi
TEL 022-717-7262
Email idee@diana.dti.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunio Iizuka
Organization Tohoku University
Division name Department of Psychiatry
Zip code
Address 2-1, Seiryo-chou, Aoba-ku, Sendai-shi
TEL 022-717-7262
Homepage URL
Email idee@diana.dti.ne.jp

Sponsor
Institute Tohoku University, Department of Psychiatry
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 Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 07 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 No longer recruiting
Date of protocol fixation
2012 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 31 Day
Last modified on
2017 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010362

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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