UMIN-CTR Clinical Trial

Basic information
Public title	Cognitive training for schizophrenia: a randomized controlled trial
Acronym	Cognitive training for schizophrenia: a randomized controlled trial
Scientific Title	Cognitive training for schizophrenia: a randomized controlled trial
Scientific Title:Acronym	Cognitive training for schizophrenia: a randomized controlled trial
Region	Japan

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

Objectives
Narrative objectives1	To evaluate effects of cognitive training for schizophrenia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brief Assessment of Cognition in Schizophrenia (BACS)
Key secondary outcomes	Schizophrenia Cognition Rating Scale (SCoRS) Intrinsic motivation inventory (IMI) Quality of Life Scale (QLS) Positive and Negative Syndrome Scale (PANSS) Scale for the Assessment of Negative Symptoms (SANS) Global Assessment of Functioning (GAF)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are 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 training. 12 weeks, 2 computer and 1 group meeting sessions/week.
Interventions/Control_2	Treatment as usual
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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	schizophrenia or schizoaffective disorder based on DSM-5
Key exclusion criteria	mental retardation; alcohol or drug dependence; history of neurological disorders
Target sample size	86

Research contact person
Name of lead principal investigator	1st name Masayoshi Middle name Last name Kobayashi
Organization	Shinshu University
Division name	School of Health Sciences, Faculty of Medicine
Zip code	396-8621
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2403
Email	mkobaya@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Ayumi Middle name Last name Yamanushi
Organization	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Division name	Department of Rehabilitation
Zip code	386-0401
Address	3057-1, Shiogawa, Ueda, Nagano, Japan
TEL	0268-35-0305
Homepage URL
Email	ot@seitaikai.or.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shinshu University
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel	0263-37-2572
Email	mdrinri@shinshu-u.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	医療法人清泰会メンタルサポートそよかぜ病院（長野県）

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 18 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	Enrolling by invitation
Date of protocol fixation	2020 Year 02 Month 04 Day
Date of IRB	2020 Year 02 Month 04 Day
Anticipated trial start date	2020 Year 02 Month 18 Day
Last follow-up date	2022 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	2020 Year 02 Month 18 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045042