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

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 PROMPT office

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
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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name