UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029874
Receipt number R000033918
Scientific Title Natural Language Processing on SNS Data to Extract Features of Psychiatric Disorders: A Pilot Study
Date of disclosure of the study information 2017/11/08
Last modified on 2021/10/14 15:56:24

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Basic information

Public title

Natural Language Processing on SNS Data to Extract Features of Psychiatric Disorders: A Pilot Study

Acronym

Natural Language Processing on SNS Data to Extract Features of Psychiatric Disorders: A Pilot Study

Scientific Title

Natural Language Processing on SNS Data to Extract Features of Psychiatric Disorders: A Pilot Study

Scientific Title:Acronym

Natural Language Processing on SNS Data to Extract Features of Psychiatric Disorders: A Pilot Study

Region

Japan


Condition

Condition

1. Patients with major depressive disorder, bipolar I/II disorder, schizophrenia, anxiety disorders, and major/mild neurocognitive disorder by DSM-5
2. Healthy volunteers

Classification by specialty

Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop an algorithm to identify features of major depressive disorder, bipolar I/II disorder, schizophrenia, anxiety disorders, and major/mild neurocognitive disorder utilizing natural language processing based on SNS text.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To see if the data collection according to the protocol is feasible and to identify the problems to conduct further study.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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)
Out/in-patients at the study site diagnosed as Major Depressive Disorder, Bipolar I/II Disorder, Schizophrenia, Anxiety Disorders, Major/Mild Neurocognitive Disorder, according to DSM-5.
(2) 20 years old or older.
(3) Decisionally not impaired judged by treating physician. If judged as decisionally impaired, patients' guardians should give consent.

As healthy volunteers
(1) Healthy volunteers who offered to participate to the study through web site.
(2) 20 years old or older.

Key exclusion criteria

As patients
(1) Patients whose illness can exacerbate by interview of the study.
(2) Patients who have comorbidities that can interfere with posting to social network service; such as patients with hand paralysis or visual impairment.
(3) Those who are considered to be ineligible by the PI or investigators.

As healthy volunteers
(1) Those who have comorbidities that can interfere with posting to social network service; such as patients with hand paralysis or visual impairment.
(2) Those who are considered to be ineligible by the PI or investigators.

Target sample size

30


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

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

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN

TEL

03-5363-3492

Homepage URL


Email

m-kitazawa@keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency (JST)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Shizuoka University

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

03-3353-1211

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)


Other administrative information

Date of disclosure of the study information

2017 Year 11 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

30

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

2017 Year 10 Month 06 Day

Date of IRB

2018 Year 06 Month 25 Day

Anticipated trial start date

2017 Year 11 Month 08 Day

Last follow-up date

2022 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients (n=5 for each diagnosis) who are diagnosed as 1) major depressive disorders or bipolar I/II disorder, 2) schizophrenia, 3) anxiety disorders, 4) major/mild neurocognitive disorder according to DSM-5 and healthy volunteers (n=10) are collected their input texts on social network service.
In addition, patients are assessed their symptom severity by rating scales respectively shown below.

1) Major depressive disorders or bipolar I/II disorder
Hamilton rating scale for depression
Young mania rating scale
2) Schizophrenia
Brief psychiatric rating scale
3) Anxiety Disorders
The state-trait anxiety inventory
4) Major/mild neurocognitive disorder
Clinical dementia rating
Mini-mental scale examination

Data collected are analyzed utilizing natural language processing and the features that are related to each diagnosis are identified through machine learning approach.

Through this procedure, sample size calculation will be conducted.


Management information

Registered date

2017 Year 11 Month 08 Day

Last modified on

2021 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033918


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name