UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009809 |
|---|---|
| Receipt number | R000010624 |
| Scientific Title | Standardization of Glasgow Sensory Questionnaire(GSQ) Japanese version |
| Date of disclosure of the study information | 2013/01/19 |
| Last modified on | 2014/01/27 12:14:13 |
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Basic information
Public title
Standardization of Glasgow Sensory Questionnaire(GSQ) Japanese version
Acronym
Standardization of Glasgow Sensory Questionnaire(GSQ) Japanese version
Scientific Title
Standardization of Glasgow Sensory Questionnaire(GSQ) Japanese version
Scientific Title:Acronym
Standardization of Glasgow Sensory Questionnaire(GSQ) Japanese version
Region
| Japan |
Condition
Condition
Pervasive developmental disorder(; PDD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We develop Japanese version of GSQ to measure sensory sensitivity, and we investigate validity of this test. We also investigate the link of sensory sensitivity in PDD compared with nomal controls.
Basic objectives2
Others
Basic objectives -Others
validity of test, clinical characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validity of GSQ (ex. internal consistency)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients: patients with diagnoses of Pervasive developmental disorder based on DSM-4 in age 20 to 65, who are inpatients or outpatients of Karasuyama hospital, Showa university school of medicine, and who volunteer to participate in the study after receiving an adequate explanation about study.
Normal control group: people in age 20 to 65, who don't have any serious psychiatric or physical illness
Key exclusion criteria
Patients: patients who have any other psychiatric or physical illness.
Nomal control group: people who have any serious psychiatric or physical illness.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Tani |
Organization
Karasuyama Hospital,Showa University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
6-11-11 Kitakarasuyama, Setagayaku, Tokyo 157-0061, Japan
TEL
03-3300-5231
tanimambo@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Takayama |
Organization
Karasuyama Hospital,Showa University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
6-11-11 Kitakarasuyama, Setagayaku, Tokyo 157-0061, Japan
TEL
03-3300-5231
Homepage URL
ytala@med.showa-u.ac.jp
Sponsor or person
Institute
Karasuyama Hospital,Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Karasuyama Hospital,Showa University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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 | 01 | Month | 19 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case control sampling
Management information
Registered date
| 2013 | Year | 01 | Month | 19 | Day |
Last modified on
| 2014 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010624
