UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	New assessment and neural basis of working memory impairment in schizophrenia
Title of the study (Brief title)	Assessment of 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 new method of assessing working memory impairment in schizophrenia using fMRI
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Association between brain activation and behavioral parameters using new delayed response task focused on central executive system and behavioral indices as below. PANSS BACS CSB JART-25
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	(1)Twenty 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. (2)Twenty healthy controls aged 20-60 years old without any history of psychiatric and neurological illness, who consented to participate in the study
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	40

Research contact person
Name of lead principal investigator	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
Email	ktakeda@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 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	2012 Year 12 Month 15 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date	2018 Year 07 Month 31 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	Part of the data of patients with schizophrenia obtained in this study would be used as pre-training data in the intervention study of the cognitive remediation therapy in schizophrenia.

Management information
Registered date	2013 Year 01 Month 14 Day
Last modified on	2017 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011450