UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057048 |
|---|---|
| Receipt number | R000065200 |
| Scientific Title | Indicators contributing to symptom improvement and treatment outcome prediction for gaming disorder and alcohol use disorder using audiovisual stimuli |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/02/16 18:34:18 |
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Basic information
Public title
Indicators contributing to symptom improvement and treatment outcome prediction for gaming disorder and alcohol use disorder using audiovisual stimuli
Acronym
Indicators contributing to symptom improvement and treatment outcome prediction for gaming disorder and alcohol use disorder using audiovisual stimuli
Scientific Title
Indicators contributing to symptom improvement and treatment outcome prediction for gaming disorder and alcohol use disorder using audiovisual stimuli
Scientific Title:Acronym
Indicators contributing to symptom improvement and treatment outcome prediction for gaming disorder and alcohol use disorder using audiovisual stimuli
Region
| Japan |
Condition
Condition
gaming disorder, alcohol use disorder, healthy controls
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of indicators contributing to symptom improvement for gaming disorder and alcohol use disorder
Basic objectives2
Others
Basic objectives -Others
Development of indicators contributing to treatment outcome prediction for gaming disorder and alcohol use disorder
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
task parameter changes and clinical symptom improvement
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
Internet gaming disorder
1) Aged between 18 and 59
2) Diagnosed with internet gaming disorder (DSM-5) based on SCID
3) Capability of informed consent
Alcohol use disorder
1) Aged between 18 and 59
2) Diagnosed with alcohol use disorder (DSM-5) based on SCID
3) Capability of informed consent
Healthy controls
1) Aged between 18 and 59
2) Confirmed to have no mental disorders based on SCID
3) Subjects who enjoy games or alcohol adequately
3) Capability of informed consent
Key exclusion criteria
Internet gaming disorder
1) Individuals in a mental state that makes it difficult to understand the purpose of the study.
2) Diagnosed with a substance use disorder (excluding nicotine) within the past 12 months according to the SCID.
3) Diagnosed with schizophrenia or bipolar I disorder according to the SCID.
4) Individuals with a history of neurological diseases (e.g., brain tumors, cerebrovascular disorders, epilepsy) or head trauma.
5) Individuals with contraindications for MRI.
6) Individuals who are judged as unsuitable for participation in this study.
Alcohol use disorder
1) Individuals in a mental state that makes it difficult to understand the purpose of the study.
2) Diagnosed with a substance use disorder (excluding alcohol and nicotine) within the past 12 months according to the SCID.
3) Diagnosed with schizophrenia or bipolar I disorder according to the SCID.
4) Individuals with a history of neurological diseases (e.g., brain tumors, cerebrovascular disorders, epilepsy) or head trauma.
5) Individuals with contraindications for MRI.
6) Individuals who are judged as unsuitable for participation in this study.
Healthy controls
1) Individuals with a history of mental disorders.
2) Individuals with a history of neurological diseases (e.g., brain tumors, cerebrovascular disorders, epilepsy) or head trauma.
3) Individuals with contraindications for MRI.
4) Individuals who are judged as unsuitable for participation in this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Fujino |
Organization
Institute of Science Tokyo
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
Institute of Science Tokyo
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
Institute of Science Tokyo
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
Institute of Science Tokyo 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
| 2025 | Year | 02 | Month | 17 | 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
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 02 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065200
