UMIN-CTR Clinical Trial

Basic information
Public title	Study on long-term improvement effect of cognitive function in schizophrenic patients by cognitive rehabilitation
Acronym	Long-term improvement effect of cognitive rehabilitation
Scientific Title	Study on long-term improvement effect of cognitive function in schizophrenic patients by cognitive rehabilitation
Scientific Title:Acronym	Long-term improvement effect of cognitive rehabilitation
Region	Japan

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

Objectives
Narrative objectives1	To investigate the long-term effects of cognitive rehabilitation (NEAR) on patients diagnosed with schizophrenia or schizophrenia emotional disorder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	BACS-J
Key secondary outcomes	SWNS,SECL

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	NEAR
Interventions/Control_2	Normal day care treatment only
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	14 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Those diagnosed with schizophrenia or schizophrenia emotional disorder according to DSM5 diagnostic criteria 2) Those aged 13 to 65 years (according to NEAR Implementation Manual 4) 3) Patients who have received normal treatment and NEAR or normal treatment only in DC, and have passed BACS for more than 6 months 4) A person who has received sufficient explanation for participation in the study and has obtained written consent based on the patient's free will
Key exclusion criteria	1) Those whose medical condition is unstable and it is difficult to conduct a follow-up survey 2) Persons with intellectual disability, alcohol / drug dependence, dementia, epilepsy, etc. 3) Persons who are judged to be ineligible by the attending physician or the research supervisor
Target sample size	62

Research contact person
Name of lead principal investigator	1st name Masayoshi Middle name Last name Kobayashi
Organization	Shinshu University School of Medicine
Division name	School of Medicine
Zip code	390-8621
Address	3-1-1 Asahi Matsumoto City
TEL	0263-37-2403
Email	mkobaya@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Tatsuro Middle name Last name Iwane
Organization	Kyoto Prefectural Shonan Hospital
Division name	Rehabilitation center
Zip code	611-0011
Address	2 Gokasho Hirookadani, Uji City
TEL	0774-32-5900
Homepage URL
Email	t-iwane4649@rakunan-hosp.jp

Sponsor
Institute	Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Self-procurement
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto Prefectural Shonan Hospital
Address	2 Gokasho Hirookadani, Uji City
Tel	0774-32-5900
Email	t-iwane4649@rakunan-hosp.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

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 31 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	Preinitiation
Date of protocol fixation	2019 Year 08 Month 06 Day
Date of IRB	2019 Year 08 Month 06 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 20 Day
Last modified on	2019 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043044