UMIN-CTR Clinical Trial

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 Hiroo Middle name Last name Matsuoka
Organization	Tohoku University
Division name	Department of Psychiatry
Zip code	9808575
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 Kunio Middle name Last name Iizuka
Organization	Tohoku University
Division name	Department of Psychiatry
Zip code	9808575
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	Tohoku University Graduate School of Medicine Ethics Committee
Address	2-1, Seiryo-chou, Aoba-ku, Sendai-shi
Tel	022-717-8006
Email	med-kenkyo@grp.tohoku.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	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	32
Results	.
Results date posted	2021 Year 09 Month 08 Day
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	2012 Year 08 Month 31 Day
Date of IRB	2012 Year 08 Month 17 Day
Anticipated trial start date	2012 Year 09 Month 07 Day
Last follow-up date	2014 Year 08 Month 26 Day
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	2021 Year 09 Month 08 Day

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