UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023764 |
|---|---|
| Receipt number | R000027146 |
| Scientific Title | Development of objective measures for depression, bipolar disorder and dementia by quantifying facial expression, body movement, and voice data during clinical interview and daily activity utilizing wearable device |
| Date of disclosure of the study information | 2016/08/25 |
| Last modified on | 2022/08/30 10:06:00 |
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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 during clinical interview and daily activity utilizing wearable device
Acronym
Development of objective measures for depression, bipolar disorder and dementia by quantifying facial expression, body movement, voice, and daily activity
Scientific Title
Development of objective measures for depression, bipolar disorder and dementia by quantifying facial expression, body movement, and voice data during clinical interview and daily activity utilizing wearable device
Scientific Title:Acronym
Development of objective measures for depression, bipolar disorder and dementia by quantifying facial expression, body movement, voice, and daily activity
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 machine learning algorithm to provide objective measures for depression, bipolar disorder and dementia utilizing facial expression, body movement, voice, and daily activity data.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comprehensive severity score based on facial expression, body movement, voice, and daily activity data produced by machine learning
Key secondary outcomes
1)Machine learning-severity score based on facial expression data
2)Machine learning-severity score based on body movement data
3)Machine learning-severity score based on voice data (mainly using the acoustic features)
4)Machine learning-severity score based on voice data (mainly using the features such as speed of speech, time to reply)
5)Machine learning-severity score based on text data
6)Machine learning-severity score based on daily activity data
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
1)Collect demographical/clinical characteristics from chart, participant and treating physician
2)Video/infrared/voice recording during a 10-minute conversation with psychiatrist and/or psychologist. Total number of recordings will be up to 10 times during the study period. Recording will be done during the doctor visit and the interval of the recording will not be fixed
3)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): 10 minutes**
Geriatric Depression Scale (GDS): 5 minutes**
(*Applied to patients with depression and bipolar disorder. **Applied to patients with dementia, mild cognitive impairment, or subjective cognitive impairment. All rating scales including * and ** will be applied to healthy volunteers)
4)To those who are willing to consent to the optional part: Wear wrist band type sensor to collect daily activity data until the next assessment.
5)except healthy volunteers are diagnosed using Structured Clinical Interview for DSM-IV-TR (SCID) any time during the follow up.
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
Inclusion criteria:
As patients
(1)
a) Out/in-patients at study sites diagnosed as depressive disorder or bipolar disorder
b) Out/in-patients at study sites diagnosed as dementia, mild cognitive impairment, or subjective cognitive impairment
(2) 20 years old or older
(3) Decisionally not impaired judged by treating physician. If judged as decisionally impaired, patients' guardians can give consent
As healthy volunteers
(1) Healthy volunteers who are offered participation to the study through web site.
Key exclusion criteria
Exclusion Criteria:
As patients
(1) Patients whose illness can be exacerbated by interview of the study.
(2) Patients who have comorbidities that can interfere with measurements in the study; such as patients with facial palsy or involuntary movement, patients with quadriplegic palsy or involuntary motion, patients with dysphonia by laryngectomy.
(3) Those who are considered to be ineligible by the PI or investigators.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kishimoto |
| Middle name | |
| Last name | Taishiro |
Organization
Keio University School of Medicine
Division name
Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes
Zip code
106-0032
Address
Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan
TEL
03-5786-0006
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 PROMPT office
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
Oizumi hospital
Oizumi mental clinic
Asakadai mental clinic
Tsurugaoka garden hospital
Nagatsuta ikoinomori clinic
Sato hospital
Biwako hospital
Komagino hospital
Asaka hospital
Tokyo Institute of Technology
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
0353633961
med-rinri-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（東京都）
大泉病院（東京都）
大泉メンタルクリニック（東京都）
あさか台メンタルクリニック（埼玉県）
鶴が丘ガーデンホスピタル（東京都）
長津田いこいの森診療所（神奈川県）
佐藤病院（山形県）
琵琶湖病院（滋賀県）
駒木野病院（東京都）
あさかホスピタル（福島県）
東京工業大学情報理工学院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 25 | Day |
Last modified on
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027146
