UMIN-CTR Clinical Trial

Basic information
Public title	Development of objective measures for depression, bipolar disorder and dementia by quantifying facial expression, body movement and voice data: A pilot study
Acronym	Development of objective measures for depression, bipolar disorder and dementia by quantifying facial expression, body movement and voice data: A pilot study
Scientific Title	Development of objective measures for depression, bipolar disorder and dementia by quantifying facial expression, body movement and voice data: A pilot study
Scientific Title:Acronym	Development of objective measures for depression, bipolar disorder and dementia by quantifying facial expression, body movement and voice data: A pilot study
Region	Japan

Condition
Condition	1. Patients with depressive disorder or bipolar disorder 2. Patients with dementia, mild cognitive impairment, or subjective cognitive impairment 3. Healthy volunteers
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop objective measures utilizing machine learning approach based on video, infrared, and voice data during conversation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To examine the feasibility and safety of data collection according to the current protocol.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Video/infrared/voice recording during 10 minutes conversation with psychiatrist and/or psychologist. Total number of recording will be 5 times or less. Recording will be done on the doctor visit and the interval of the recording will not be fixed (20 days or longer for healthy volunteers). Clinical severity assessment using rating scales as follows. Hamilton Rating Scale for Depression (HAM-D): 20 minutes Montgomery Asberg Depression Rating Scale (MADRS): 10 minutes Young mania rating scale (YMRS): 10 minutes Beck depression inventory (BDI): 3 minutes pittsburgh sleep quality index (PSQI): 2 minutes Clinical Dementia Rating(CDR): 15 minutes Mini-mental Scale Examination (MMSE): 15 minutes Wechsler Memory Scale-Logical Memory Subtest: 5 minutes Clock drawing test (CDT): 3 minutes Neuropsychiatric Inventory (NPI): 10minutes Geriatric Depression Scale (GDS): 5 minutes
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	Not applicable
Gender	Male and Female
Key inclusion criteria	As patients (1) a) Out/in-patients at Keio university hospital diagnosed as depressive disorder or bipolar disorder b) Out/in-patients at Keio university hospital diagnosed as dementia, mild cognitive impairment, or subjective cognitive impairment (2) 20 years old or older (3) Decisionally not impaired judged by treating physician As healthy volunteers (1) Healthy volunteers who offered participation to the study through web site.
Key exclusion criteria	As patients (1) Patients whose illness can be exacerbated by the interview of the study. (2) Patients who have comorbidities that can interfere with the measurements in the study; such as patients with facial palsy or involuntary movement, patients with quadriplegic palsy or involuntary motion, patients with dysphonia by laryngectomized. (3) Those who are considered to be ineligible by the PI or investigators. As healthy volunteers (2) and (3) described above
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Taishiro Middle name Last name Kishimoto
Organization	Keio University School of Medicine
Division name	Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes
Zip code	06-0032
Address	Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan
TEL	03-5363-3492
Email	tkishimoto@keio.jp

Public contact
Name of contact person	1st name Momoko Middle name Last name Kitazawa
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL	03-5363-3492
Homepage URL	https://www.i2lab.info/prompt
Email	m-kitazawa@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Keio University Science and Technology Omron corporation Advanced Media corporation FRONTEO Healthcare, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Clinical and Translational Research Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel	03-5363-3961
Email	med-nintei-jimu@adst.keio.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	慶應義塾大学病院（Keio University Hospital）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 08 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	20
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	Completed
Date of protocol fixation	2016 Year 03 Month 03 Day
Date of IRB	2016 Year 03 Month 09 Day
Anticipated trial start date	2016 Year 03 Month 10 Day
Last follow-up date	2018 Year 12 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Method: 1) 10 minutes conversation. 2) Severity assessments using rating scales that are used for depression, bipolar disorder or dementia. 3) Demographic characteristics extraction from medical charts. Video/infrared/voice recording will be taken place for 1) and 2). Utilizing machine learning approach, we will quantify such patients data and develop the algorithm that has strong correlation with clinical rating scale.

Management information
Registered date	2016 Year 03 Month 08 Day
Last modified on	2022 Year 09 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024677