UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051562 |
|---|---|
| Receipt number | R000058828 |
| Scientific Title | A study of decision-making in social situations in psychiatric disorders |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/09/17 17:48:17 |
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Basic information
Public title
A study of decision-making in social situations in psychiatric disorders
Acronym
A study of decision-making in social situations in psychiatric disorders
Scientific Title
A study of decision-making in social situations in psychiatric disorders
Scientific Title:Acronym
A study of decision-making in social situations in psychiatric disorders
Region
| Japan |
Condition
Condition
healthy subjects, individuals with psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, obsessive compulsive disorder, gaming disorder, autism spectrum disorder, attention deficit hyperactivity disorder, epilepsy)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify the decision-making in various psychiatric disorders
Basic objectives2
Others
Basic objectives -Others
To investigate the mechanisms of altered decision-making in psychiatric disorders
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
parameters in behavioral tasks of decision-making
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
| 18 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy group
1) Aged 18-59 years-old
2) Capability of informed consent
Clinical group
1) Subjects who had received a clinical diagnosis of psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, obsessive compulsive disorder, gaming disorder, autism spectrum disorder, attention deficit hyperactivity disorder, epilepsy) at department of psychiatry of the Tokyo Medical and Dental University Hospital.
2) Aged 18-59 years-old
3) Capability of informed consent
Key exclusion criteria
Healthy group
1) Serious psychiatric disorders or medical illness.
2) Subjects who are judged as unsuitable for participation in this study
Clinical group
1) Serious medical illness.
2) Subjects who are judged as unsuitable for participation in this study
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Fujino |
Organization
Tokyo Medical and Dental University
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5238
jf15psyc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Fujino |
Organization
Tokyo Medical and Dental University
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5238
Homepage URL
jf15psyc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Ethics Review Committee, School of Medicine
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
syomu1.adm@tmd.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | 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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2023 | Year | 07 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058828
