UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023764
Receipt No. 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 2019/09/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Department of Neuropsychiatry
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3971
Email tkishimoto@keio.jp

Public contact
Name of contact person
1st name Kitazawa
Middle name
Last name Momoko
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 keio@prompt-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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
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
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.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


Contact us.