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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021396
Receipt No. 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 2019/03/12

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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 Department of Neuropsychiatry
Zip code 1608582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3971
Email tkishimoto@keio.jp

Public contact
Name of contact person
1st name Taishiro
Middle name
Last name Kishimoto
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3971
Homepage URL https://www.i2lab.info/prompt
Email tkishimoto@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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 10 Day
Last follow-up date
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
2019 Year 03 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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