UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of an assessment tool and cognitive rehabilitation strategy for working memory impairment in schizophrenia
Title of the study (Brief title)	Assessment and cognitive rehabilitation for working memory impairment in schizophrenia
Region	Japan

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

Objectives
Narrative objectives1	To develop a cognitive rehabilitation strategy for working memory impairment in schizophrenia assessed using fMRI
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Brain activation and behavioral parameters using new delayed response task focused on central executive system along with verbal N-back task and non-verbal N-back task PANSS BACS CSB JART-25
Key secondary outcomes	UPSA-B SFS SLOF SF36 FEIT-J Hinting task SCSQ

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	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Cognitive training focused on working memory consisting of two 45 min computer sessions (computer soft) and a 45 min verbal session (group meeting) per week during 12 weeks
Interventions/Control_2	Cognitive training (NEAR) treating a broad range of cognition consisting of two 45 min computer sessions (computer soft) and a 45 min verbal session (group meeting) per week during 12 weeks
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	Forty-five patients with schizophrenia according to the DSM-IV criteria recruited from outpatients and inpatients of National Center Hospital, National Center of Neurology and Psychiatry (NCNP). All patients were 20-60 years old and had the capacity to give written informed consent.
Key exclusion criteria	(1)Patients with the estimated IQ lower than 80 (by Japanese Adult Reading Test) (2)Patients with history of organic brain disorder, dementia, pervasive developmental disorder, or substance/alcohol dependence. (3)Patients with severe irritation that hindered them from being seated still during the experiment. (4)Patients for whom changes in medication were presumed to be necessary during the study
Target sample size	64

Research contact person
Name of lead principal investigator	Kazuyuki Nakagome
Organization	National Center of Neurology and Psychiatry
Division name	National Institute of Mental Health
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2711
Email	nakagome@ncnp.go.jp

Public contact
Name of contact person	Kazuyoshi Takeda
Organization	National Center Hospital, National Center of Neurology and Psychiatry
Division name	Department of Psychiatry
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2711
Homepage URL
Email	ktakeda@ncnp.go.jp

Sponsor
Institute	National Center Hospital, National Center of Neurology and 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)

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	国立精神・神経医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 02 Month 21 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Pre-training data of this intervention study would partly include the data obtained in an observational study in search for new assessment method of working memory impairment in schizophrenia.

Management information
Registered date	2013 Year 01 Month 16 Day
Last modified on	2018 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011463