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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032141
Receipt No. R000036665
Scientific Title Quantifying Psychiatric Disorders with Natural Language Processing on Conversational Data
Date of disclosure of the study information 2018/04/07
Last modified on 2019/04/08

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Basic information
Public title Quantifying Psychiatric Disorders with Natural Language Processing on Conversational Data
Acronym Natural Language Processing on Conversational Data for Psychiatric Disorders
Scientific Title Quantifying Psychiatric Disorders with Natural Language Processing on Conversational Data
Scientific Title:Acronym Natural Language Processing on Conversational Data for Psychiatric Disorders
Region
Japan

Condition
Condition 1. Patients with major depressive disorder, bipolar I/II disorder, schizophrenia, anxiety disorders (or obsessive-compulsive disorder), and major/mild neurocognitive disorder by DSM-5 or ICD-10
2. Healthy volunteers
Classification by specialty
Psychiatry
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 (or obsessive-compulsive disorder), and major/mild neurocognitive disorder utilizing natural language processing based on subjects' speech.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Linguistic features of each psychiatric diagnosis identified through natural language processing and machine learning
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 sites diagnosed as Major Depressive Disorder, Bipolar I/II Disorder, Schizophrenia, Anxiety Disorders (or Obsessive-compulsive disorder), Major/Mild Neurocognitive Disorder, according to DSM-5 or ICD-10.
(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 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 300

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
Email tkishimoto@keio.jp

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Eguchi
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 http://www.i2lab.jp/underpin/
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
Oizumi hospital
Oizumi mental clinic
Asakadai mental clinic
Tsurugaoka garden hospital
Nagatsuta ikoinomori clinic
Biwako hospital
Sato hospital
Komagino hospital
Asaka hospital
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)
静岡大学(静岡県)
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)
琵琶湖病院(滋賀県)
佐藤病院(山形県)
駒木野病院(東京都)
あさかホスピタル(福島県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 07 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
2018 Year 02 Month 01 Day
Date of IRB
2018 Year 04 Month 02 Day
Anticipated trial start date
2018 Year 04 Month 07 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients (n=50 for each diagnosis) who are diagnosed as 1) major depressive disorders or bipolar I/II disorder, 2) schizophrenia, 3) anxiety disorders (or Obsessive-compulsive disorder), 4) major/mild neurocognitive disorder according to DSM-5 or ICD-10 are interviewed by a psychologist for 30 to 60 minutes. The content of the interview includes symptoms, hobby, daily lifestyle, explanation about a paintings etc. Healthy volunteers (n=100) go through the same interview. Each participant receives the interview at least twice and not more than five times.
In addition, patients are assessed their symptom severity by rating scales respectively shown below.

1) Major depressive disorders, bipolar I/II disorder, anxiety disorders (including obsessive-compulsive disorder)
Hamilton rating scale for depression
Young mania rating scale
The state-trait anxiety inventory
Hamilton Rating for Anxiety

2) Schizophrenia
Positive and Negative Syndrome Scale

3) Major/mild neurocognitive disorder
Clinical Dementia Rating (CDR)
Mini-mental Scale Examination (MMSE)
Montreal Cognitive Assessment-Japanese
Wechsler Memory Scale-Revised Logical Memory

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

Management information
Registered date
2018 Year 04 Month 07 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036665

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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