UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012671 |
|---|---|
| Receipt number | R000014810 |
| Scientific Title | Validation of the Specific Levels of Functioning Scale - Japanese version |
| Date of disclosure of the study information | 2013/12/24 |
| Last modified on | 2017/12/27 09:09:36 |
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Basic information
Public title
Validation of the Specific Levels of Functioning Scale - Japanese version
Acronym
Validation of SLOF-Japanese version
Scientific Title
Validation of the Specific Levels of Functioning Scale - Japanese version
Scientific Title:Acronym
Validation of SLOF-Japanese version
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement of social and functional outcome should be an ultimate goal in the treatment of patients with schizophrenia. Among several social/functional outcome meausres used so far, the Specific Levels of Functioning Scale, or SLOF,requires minimal administration time. The aim of this study is to determine the validity of the SLOF-Japanese version that is expected to provide a promising assessment tool in Japan.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BACS Japanese version
UPSA-B Japanese version
SLOF Japanese version
SFS Japanese version
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. Meeting DSM-IV-TR criteria for schizophrenia at the time of assessment
2. Regularly visiting outpatient clinic
3. 20 years or older. Less than 60 years old
4. Presence of a family member or caregiver capable of assessing social/functional status of participants
5. Capable of understanding the aims and nature of the study, and giving informed consent to participate in it.
Key exclusion criteria
1. Present or past history of severe brain organicity and/or injury accompnied with conciousness loss lasting more than 10 minutes.
2. Co-morbid alcohol/substance use, besides caffeine and nicotine, within the last 12 months
3. Meeting DSM4-TR Axis 2 criteria, i.e. personality disorder or mental retardation.
4. Other conditions deemed to affect the study eligibility
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Nakagome |
Organization
National Center of Neurology and Psychiatry
Division name
Institute of Mental Health
Zip code
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL
042-341-2711
nakagome@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomiki Sumiyoshi |
Organization
National Center of Neurology and Psychiatry
Division name
Translational Medical Center
Zip code
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL
042-341-2712-8011
Homepage URL
sumiyot@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Foundation for Neuroscience and Mental Health
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 24 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 25 | Day |
Other
Other related information
Among the assessment tools, SLOF-Japanese version (patient and caregiver forms) , SFS-Japanese version (self assessment), and BCI-J are filled out at home. Other assessments are conducted at medical facilities.
Management information
Registered date
| 2013 | Year | 12 | Month | 24 | Day |
Last modified on
| 2017 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014810
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
