UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Reliability and validity of the Specific Levels of Functioning Scale (SLOF) Japanese version
Title of the study (Brief title)	Reliability and validity of the Specific Levels of Functioning Scale (SLOF) Japanese version
Region	Japan

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

Objectives
Narrative objectives1	We examined the reliability and validity of the Japanese version of the Specific Levels of Functioning Scale (SLOF).
Basic objectives2	Others
Basic objectives -Others	Individuals with schizophrenia show impairment in various aspects of daily lives. The Specific Levels of Functioning Scale(SLOF) by Schneider et al. was developed to measure the behavioral functioning and daily living skills of patients with schizophrenia. We examined the reliability and validity of the Japanese version of the SLOF.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Neurocognitive function: BACS-J (Brief Assessment of Cognitive function in Schizophrenia Japanese version) Social function: UPSA-B (Japanese version) Real-world functonal outcome: SLOF(Specific Levels of Functioning Assessment)Japanese version, SFS(Social Functioning Scale) Japanese version
Key secondary outcomes	Psychiatric symptoms: PANSS(Positive and Negative Syndrome Scale) Social cognitive function: Hinting task Japanese version, SCSQ-J(Social Cognition Screening Questionnaire Japanese version) Meta cognitive function: BCIS-J(Beck Cognitive Insight Scale Japanese version) Global function: GAF(Global Assessment of Functioning) Premorbid intellectual funton: JART(Japanese Adult Reading Test) Backgroud factors: age, sex, dominat hand, schooling history, family history, morbidity period, recurrence, administration, complications, past history, ECT, medication

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	The patient who (1)is diagnosed as schizophrenia by using DSM-4-TR (2)is outpatient (3)is 20 years old and over and under 60 years old (4)has family or caregiver who can assess his/her real-world functional outcome (5)can understand the aim and contents of this study and agree with this study.
Key exclusion criteria	The patient who (1)have severe cerebral organic disease or brain injury, now or before. (2)alcohol or substance use disorder (exclude caffein or nicotine use). (3)who diagnosed as axis-2 of DSM-4-TR(personality disorder or mental retardation). (4)is regarded as inappropriate for this study by the researcher.
Target sample size	5

Research contact person
Name of lead principal investigator	Hidehito Niimura
Organization	School of Medicine, Keio University
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-5363-3829
Email	niimura-hide@nifty.ne.jp

Public contact
Name of contact person	Hidehito Niimura
Organization	School of Medicine, Keio University
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-5363-3829
Homepage URL
Email	niimura-hide@nifty.ne.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	Japanese Foundation for Neuroscience and Mental Health
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Center of Neurology and Psychiatry Department of Psychiatry, Hokkaido University Graduate School of Medicine Department of Neuropsychiatry, School of Medicine, Sapporo Medical University Department of Psychiatry, School of Medicine, Tokyo Women's Medical University Department of Psychiatry, School of Medicine, Showa University Department of Psychiatry, School of Medicine, Nara Medical University Department of Neuropsychiatry, School of Medicine, Kansai Medical University Hizen Psychiatric Center Department of Neuropsychiatry, School of Medicine, Oita University Department of Psychiatry, School of Medicine, University of Occupational and Environmental Health
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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 14 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 07 Day
Anticipated trial start date	2014 Year 05 Month 16 Day
Last follow-up date	2014 Year 06 Month 30 Day
Date of closure to data entry	2014 Year 07 Month 15 Day
Date trial data considered complete	2014 Year 08 Month 01 Day
Date analysis concluded	2015 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Sumiyoshi T, Nishida K, Niimura H, Toyomaki A, Morimoto T, Tani M, Inada K, Ninomiya T, Hori H, Manabe J, Katsuki A, Kubo T, Koshikawa Y; Shirahama M, Kohno K, Kinoshita T, Kusumi I, Iwanami A, Ueno T, Kishimoto T, Terao T, Nakagome K: Validation of the Specific Level of Function Scale: Japanese version; Relation to cognitive insight. Schizophrenia Research: Cognition 6: 9-14, 2016

Management information
Registered date	2014 Year 05 Month 14 Day
Last modified on	2017 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016258