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

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 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

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

Value
https://center6.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