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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027080
Receipt No. 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 2017/10/20

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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
Middle name
Last name Taishiro Kishimoto
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3971
Email tkishimoto@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taishiro Kishimoto
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3971
Homepage URL
Email tkishimoto@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Address
Tel
Email

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
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
Anticipated trial start date
2017 Year 04 Month 21 Day
Last follow-up date
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
2017 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030791

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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