UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021396 |
|---|---|
| Receipt number | R000024677 |
| Scientific Title | Development of objective measures for depression, bipolar disorder and dementia by quantifying facial expression, body movement and voice data: A pilot study |
| Date of disclosure of the study information | 2016/03/08 |
| Last modified on | 2022/09/15 10:58:11 |
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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
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
m-kitazawa@keio.jp
Sponsor or person
Institute
Keio 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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024677
