UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048854 |
|---|---|
| Receipt number | R000055667 |
| Scientific Title | Defferentiation of depressive state utilizing artificial intelligence from manic state |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2024/03/07 09:42:24 |
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Basic information
Public title
Anyone can be a great psychiatrist: Development of methods supporting treatments for bipolar disorder by improving diagnostic accuracy based on application of objective and quantitative analyses of behaviors
Acronym
Anyone can be a great psychiatrist
Scientific Title
Defferentiation of depressive state utilizing artificial intelligence from manic state
Scientific Title:Acronym
DAIM study
Region
| Japan |
Condition
Condition
Bipolar disorder, Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Testing diagnostic accuracy of methods to predict manic and depressive symptoms using artificail intelligence for integrated analysis of quantified facial expressions, voice prosody, eye gaze, sleep records and existing clinical assessments for patients with bipolar disorder and depression.
Basic objectives2
Others
Basic objectives -Others
Differentiation of unipolar depression from bipolar depression
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Young Mania Rating Scale and Hamilton
Depression Rating Scale
Key secondary outcomes
Diagnosis of depression or bipolar disorder determined with SCID-5-RV
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosis of ripolar disorder I, Bipolar disorder II, or depression
Key exclusion criteria
1. Inappropriate judged by the researcher
2. Subjects who did not consent to participate in this study
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Yamasue |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu City
TEL
053-435-2295
yamasue@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Yamasue |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu City
TEL
053-435-2295
Homepage URL
yamasue@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashiku, Hamamatsu City
Tel
053-435-2680
rinri@hama-med.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 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 31 | 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
nothing special
Management information
Registered date
| 2022 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055667
