UMIN-CTR Clinical Trial

Basic information
Public title	Research on Detection of Depression by Multimodal AI Video Analysis
Acronym	Research on Detection of Depression by Multimodal AI Video Analysis
Scientific Title	Development of Depressive Symptom Assessment Techniques Using Multimodal AI Video Analysis of Web Interviews
Scientific Title:Acronym	Development of Depressive Symptom Assessment Techniques Using Multimodal AI Video Analysis of Web Interviews
Region	Japan

Condition
Condition	Depressive Symptom
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	n this study, free conversation and mood assessment interviews will be conducted using a web conferencing system with persons who may have depressive symptoms, etc. The purpose of this study is to develop a technique for assessing depressive symptoms using a multimodal AI video analysis technique. The purpose of this study is to develop a technology for evaluating depressive symptoms by using multimodal AI video analysis technology for voice, facial expression, and text data acquired during these interviews.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Presence of psychiatric disorders: depressive episodes according to SCID-5
Key secondary outcomes	Severity assessment: MADRS, PHQ-9

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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1. those who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study fully, volunteer to participate of their own free will, and agree in writing to participate in the study 2. those who are at least 18 years of age at the time of consent 3. those who are healthy or have depressive symptoms and are already receiving counseling services or will receive counseling services in the future 4. those who have a smart phone or PC and can use web conferencing via the Internet.
Key exclusion criteria	1. those whose condition is likely to be impaired by participation in this study 2. who are deemed inappropriate by the principal investigator or co-investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Nose
Organization	I'm beside you Inc.
Division name	Chief Technology Officer
Zip code	1056415
Address	Toranomon Hills Business Tower 12 floor, Toranomon1-17-1, Minato-ku Tokyo
TEL	070-4368-4330
Email	yasuhironose@imbesideyou.world

Public contact
Name of contact person	1st name Yuna Middle name Last name Nango
Organization	I'm beside you Inc.
Division name	Chief Customer Success Officer
Zip code	1056415
Address	Toranomon Hills Business Tower 12 floor, Toranomon1-17-1, Minato-ku Tokyo
TEL	070-4368-4330
Homepage URL	https://prtimes.jp/main/html/rd/p/000000043.000066162.html
Email	yunanango@imbesideyou.world

Sponsor
Institute	I'm beside you Inc.
Institute
Department

Funding Source
Organization	I'm beside you Inc.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Healthcare Systems Co., Ltd.
Address	Shirokane 1-14-18, Showa-Ku, Nagoya-City, Aichi
Tel	03-6809-2722
Email	info@hc-sys.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	株式会社I'mbesideyou（東京都）/ I’m beside you Inc.（Tokyo） オンラインによる面談/Online interview

Other administrative information
Date of disclosure of the study information	2022 Year 11 Month 18 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 09 Month 22 Day
Date of IRB	2022 Year 10 Month 11 Day
Anticipated trial start date	2022 Year 10 Month 18 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 12 Month 31 Day
Date trial data considered complete	2023 Year 01 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other

Other related information

Observational Studies Randomization: Single arm Blinding: Open-label Control: Uncontrolled Allocation: Not conducted Method of recruitment Candidates who met the selection criteria will be selected from among the registered members of cotree, an online counseling service provider (collaborating organization), via the Web and e-mail newsletter (October-November 2022), so that there will be no bias in terms of gender, working status, etc.

Management information
Registered date	2022 Year 11 Month 15 Day
Last modified on	2022 Year 11 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056374