臨床研究等提出・公開システム

Date of registration	Dec. 26, 2021
Last modified on	May. 28, 2022
Trial ID	jRCT1030210514

Scientific Title	Development and exploration of an AI model to classify "healthy subject" and "suspected schizophrenia patient" based on free conversations with medical staff
Public Title	Development and exploration of an AI model to classify "healthy subject" and "suspected schizophrenia patient" based on free conversations with medical staff

Contact for Scientific Queries	Name	Yuichiro Tsutsumi
	Affiliation	Ongata hospita
	Address	105 Nishiterakatamachi, Hachiojishi, Tokyo Japan
	Telephone	+81-42-651-3411
	E-mail	dry.tsutsumiongata@gmail.com
Contact for Public Queries	Name	Takahashi Masato
	Affiliation	FRONTEO Inc.
	Address	2-12-23 Konan, Minato-ku, Tokyo Japan
	Telephone	+81-3-5463-6330
	E-mail	masato_takahashi@fronteo.com

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 08, 2021
Actual date of first enrollment		Dec. 08, 2021
Target sample size		150
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1) Schizophrenia Between 18 and 65 years of age at the time of consent and diagnosed with schizophrenia according to the DSM-5. 2) Healthy Subject Between the ages of 18 and 65 years old at the time of consent. 1)2) in Common Who speak Japanese as his/her mother tongue and able to have an interview (conversation with doctors and medical staff) Who can obtain written consent from the person and also his / her substitute if the subject is under 20 years old.
	Exclusion Criteria	Who has been judged by a doctor to have difficulty in having conversation due to deafness, dysarthria, aphasia, etc. Who has been diagnosed of having a pyschiatric disorder such as depression Who has been diagnosed of a dementia or judged to have cognitive dysfunction due to neurological diseases (epilepsy, stroke, etc.) Who has been judged by a doctor not to be suitable for this trial by any reasons
	Age Minimum	18age old over
	Age Maximum	65age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Schizophrenia
Primary Outcome(s)		Development and exploration of an following AI model based on free conversations with medical staff to classify "healthy subject" and "suspected schizophrenia patient" to classify the history of hospitalization for schizophrenic patient

Primary Sponsor	Sumitomo Dainippon Pharma Co., Ltd.

Secondary Sponsor

Source of Monetary Support	Sumitomo Dainippon Pharma Co., Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Yoyogi Mental Clinic Research Ethics Committee
Address	3F,4-26-11 Sendagaya,Shibuya-ku, Tokyo
Telephone	+81-3-6455-4173
E-Mail	cns_jimu@triad-j.co.jp
Approval Status	Approval
Date of approval	Dec. 06, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	May. 28, 2022	(this page)	Changes
2	Mar. 18, 2022	Detail	Changes
1	Dec. 26, 2021	Detail

List of change history