UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008144 |
|---|---|
| Receipt number | R000009521 |
| Scientific Title | Comparison of social functions between adults with AS, schizophrenia and normal control |
| Date of disclosure of the study information | 2012/06/15 |
| Last modified on | 2013/01/19 10:29:47 |
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Basic information
Public title
Comparison of social functions between adults with AS, schizophrenia and normal control
Acronym
Comparison of social functions on adults with AS
Scientific Title
Comparison of social functions between adults with AS, schizophrenia and normal control
Scientific Title:Acronym
Comparison of social functions on adults with AS
Region
| Japan |
Condition
Condition
Asperger's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with Asperger's disease have difficulty on social cognitive functions, so we compare Asperger's disease and normal controls on the scores of tasks about social cognitive functions.
Basic objectives2
Others
Basic objectives -Others
clinical characteristics, usefulness of tasks
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores of social cognitive tests
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 Asperger's disease or schizophrenia 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, who volunteer to participate in the study.
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
45
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
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
TEL
03-3300-5231
Homepage URL
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
| 2012 | Year | 06 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 19 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 19 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 19 | Day |
Other
Other related information
case control sampling
Management information
Registered date
| 2012 | Year | 06 | Month | 12 | Day |
Last modified on
| 2013 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009521
