UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder patients.
Acronym	Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder patients.
Scientific Title	Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder patients.
Scientific Title:Acronym	Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder patients.
Region	Japan

Condition
Condition	schizophrenia, major depressive disorder, bipolar disorder, and neurodevelopmental disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brief Assessment of Cognition in Schizophrenia: BACS, Self Efficacy for Community Life scale: SECL, Life Assessment Scale for Mental Ill: LASMI, and The Global Assessment of Functioning Scale: GAF after cognitive rehabilitation for 6 months
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	cognitive rehabilitation
Interventions/Control_2	twice a week, 6 months
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	49 years-old >=
Gender	Male and Female
Key inclusion criteria	schizophrenia, major depressive disorder, bipolar disorder, neurodevelopmental disorder patinets intelligence quotient more than 70 by Wechsler Adult Intelligence Scale- Third Edition, all z score of subscale of Brief Assessment of Cognition in Schizophrenia more than -2
Key exclusion criteria	nothing in particular
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Naoya Middle name Last name Kitamura
Organization	Kawasaki medical school
Division name	Depatment of Psychiatry
Zip code	701-0192
Address	577, Matsushima, Kurashiki-city, Okayama 701-0192, Japan
TEL	086-462-1111
Email	n-kitamura@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Naoya Middle name Last name Kitamura
Organization	Kawasaki medical school
Division name	Depatment of Psychiatry
Zip code	701-0192
Address	577, Matsushima, Kurashiki-city, Okayama 701-0192, Japan
TEL	086-462-1111
Homepage URL
Email	n-kitamura@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki medical school department psychiatry
Institute
Department

Funding Source
Organization	Kawasaki medical school department psychiatry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research ethics committee of Kawasaki Medical School and Kawasaki Medical School Hospital
Address	577, Matsushima, Kurashiki-city, Okayama 701-0192, Japan
Tel	086-462-1111
Email	kmsres@med.kawasaki-m.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

Other administrative information
Date of disclosure of the study information	2016 Year 08 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	6
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	due to termination of this research
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	Terminated
Date of protocol fixation	2016 Year 06 Month 30 Day
Date of IRB	2016 Year 07 Month 11 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2021 Year 07 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 04 Day
Last modified on	2020 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026516