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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008144
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Karasuyama Hospital,Showa University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009521

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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