UMIN-CTR Clinical Trial

Basic information
Public title	The effect of compensatory cognitive training for patients with schizophrenia
Acronym	The effect of compensatory cognitive training for patients with schizophrenia
Scientific Title	The effect of compensatory cognitive training for patients with schizophrenia
Scientific Title:Acronym	The effect of compensatory cognitive training for patients with schizophrenia
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of Cognitive Remediation Therapy (CRT) focusing on the cognitive function problem in schizophrenia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Neuropsychological tests, clinical symptom measures, NIRS and BDNF at pre and post intervention
Key secondary outcomes	Neuropsychological tests, clinical symptom measures, NIRS and BDNF at 3 months after intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	CRT, once a week for 3 months
Interventions/Control_2	Non-CRT
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patient who meets ICD-10 criteria for schizophrenia 2) Patients whose condition is relatively stable 3) Patient who gave written informed consent
Key exclusion criteria	1) dependence on alcohol 2) Patients who are at high risk of violence, suicide attempts, impulsive acts 3) Patients with head trauma, cerebrovascular disorders and neurodegenerative diseases 4) Patients under 16 years of age
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Yuko Middle name Last name Higuchi
Organization	University of Toyama
Division name	Department of Neuropsychiatry
Zip code	930-0152
Address	2630 Sugitani, Toyama
TEL	076-434-7323
Email	yhiguchi@med.u-toyama.ac.jp

Public contact
1st name of contact person	1st name Shotaro Middle name Last name Nakada
Organization	University of Toyama
Division name	Department of Neuropsychiatry
Zip code	930-0152
Address	2630 Sugitani, Toyama
TEL	076-434-7323
Homepage URL
Email	noutore_toyama@yahoo.co.jp

Sponsor
Institute	University of Toyama
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

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

IRB Contact (For public release)
Organization	Toyama university hospital Center for Clinical Research
Address	2630 Sugitani, Toyama
Tel	076-415-8857
Email	rinri@adm.u-toyama.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	富山大学附属病院(富山県)、砺波サナトリウム福井病院(富山県)

Other administrative information
Date of disclosure of the study information	2018 Year 06 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	41
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	Completed
Date of protocol fixation	2018 Year 06 Month 01 Day
Date of IRB	2017 Year 10 Month 10 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2019 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	2018 Year 05 Month 31 Day
Last modified on	2019 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037423