UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044026 |
|---|---|
| Receipt number | R000050273 |
| Scientific Title | Autistic traits and social cognition in patients with schizophrenia |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/04/23 20:42:01 |
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Basic information
Public title
Autistic traits and social cognition in patients with schizophrenia
Acronym
Autistic traits and social cognition in patients with schizophrenia
Scientific Title
Autistic traits and social cognition in patients with schizophrenia
Scientific Title:Acronym
Autistic traits and social cognition in patients with schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Hepato-biliary-pancreatic medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate autistic traits and social cognition in patients with schizophrenia including patients with treatment-resistant schizophrenia
Basic objectives2
Others
Basic objectives -Others
General cognitive function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autistic traits and social cognition
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Individuals who meet the criteria for schizophrenia or schizoaffective disorder with DSM-5
Healthy subjects
Key exclusion criteria
Individuals with any other mental disorder
Individuals with serious complication
Individuals without disease notification
Individuals with pregnancy/possibility of pregnancy, or lactating
Individuals with suicidal ideation
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masaomi |
| Middle name | |
| Last name | Iyo |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL
043-222-7171
iyom@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Nakata |
Organization
Chiba University Hospital
Division name
Psychiatry
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL
043-222-7171
Homepage URL
nakata.y@chiba-u.jp
Sponsor or person
Institute
Department of psychiatry, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant in-Aid for Scientific Research(KAKENHI)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University research support division
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
Tel
043-226-2462
igaku-rinri@office.chiba-u.jp
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
千葉大学医学部附属病院(千葉)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2021 | Year | 04 | Month | 23 | Day |
Last modified on
| 2021 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050273
