UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047358 |
|---|---|
| Receipt number | R000054003 |
| Scientific Title | A study of gaming disorder and alcohol use disorder using visual and auditory stimuli |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/09/17 17:51:10 |
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Basic information
Public title
A study of gaming disorder and alcohol use disorder using visual and auditory stimuli
Acronym
A study of gaming disorder and alcohol use disorder using visual and auditory stimuli
Scientific Title
A study of gaming disorder and alcohol use disorder using visual and auditory stimuli
Scientific Title:Acronym
A study of gaming disorder and alcohol use disorder using visual and auditory stimuli
Region
| Japan |
Condition
Condition
Healthy subjects
Gaming disorder
Alcohol use disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the mechanisms of addictive behaviors
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Parameters of the tasks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Visual and auditory stimuli
Interventions/Control_2
Visual and auditory stimuli
Interventions/Control_3
Visual and auditory stimuli
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) Subjects who enjoy games or alcohol adequately
3) Capability of informed consent
Gaming disorder group
1) Subjects who had received a clinical diagnosis of game disorder at department of psychiatry of the Tokyo Medical and Dental University Hospital.
2) Aged 18-59 years-old
3) Capability of informed consent
Alcohol use disorder group
1) Subjects who had received a clinical diagnosis of alcohol disorder at Hizen Psychiatric Center.
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
Gaming disorder group
1) Serious medical illness
2) Subjects who are judged as unsuitable for participation in this study
Alcohol use disorder group
1) Serious medical illness
2) Subjects who are judged as unsuitable for participation in this study
Target sample size
200
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
113-0034
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
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
113-0034
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
Homepage URL
jf15psyc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Tokyo Medical and Dental University Hospital
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5612
tiken.crc@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
| 2022 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 04 | Month | 01 | 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=R000054003
