UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027080 |
|---|---|
| Receipt number | R000030791 |
| Scientific Title | Quantifying Psychiatric Disorders with Natural Language Processing: A Pilot Study |
| Date of disclosure of the study information | 2017/04/21 |
| Last modified on | 2025/05/02 15:22:35 |
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Basic information
Public title
Quantifying Psychiatric Disorders with Natural Language Processing: A Pilot Study
Acronym
Natural Language Processing for Psychiatric disorders: A Pilot Study
Scientific Title
Quantifying Psychiatric Disorders with Natural Language Processing: A Pilot Study
Scientific Title:Acronym
Natural Language Processing for 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 major depressive disorder, bipolar I/II disorder, schizophrenia, anxiety disorders, and major/mild neurocognitive disorder utilizing natural language processing based on subjects' speech.
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
Exploratory analysis on the relation between text analysis and diagnoses and/or symptom severity.
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
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
Exclusion Criteria:
As patients
(1) Patients whose illness can exacerbate by interview of the study.
(2) Patients who have comorbidities that can interfere with measurements in the study; such as patients with dysphonia by laryngectomy.
(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 measurements in the study; such as patients with dysphonia by laryngectomy.
(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
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3971
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
Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes
Zip code
160-8582
Address
Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan
TEL
03-5786-0006
Homepage URL
tkishimoto@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
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 | 04 | Month | 21 | 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 | 03 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | 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 are interviewed by psychologist for 30 to 60 minutes. The content of the interview includes symptoms, hobby, daily life style, explanation about a paintings etc. Healthy volunteers (n=10) go through the same interview. Each participant can receive the interview up to two times.
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 is conducted.
Management information
Registered date
| 2017 | Year | 04 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030791
