臨床研究等提出・公開システム

Date of registration	Sept. 03, 2022
Last modified on	Oct. 18, 2022
Trial ID	jRCT1030220320

Scientific Title	Development and exploration of an AI model to classify "schizophrenia with signs of relapse" and "schizophrenia with no signs of relapse" based on free conversations with medical staff
Public Title	Development and exploration of an AI model to classify "schizophrenia with signs of relapse" and "schizophrenia with no signs of relapse" based on free conversations with medical staff

Contact for Scientific Queries	Name	Toyoshiba Hiroyoshi
	Affiliation	FRONTEO Inc.
	Address	2-12-23 Konan, Minato-ku, Tokyo Japan
	Telephone	+81-3-5463-6330
	E-mail	hiroyoshi_toyoshiba@fronteo.com
Contact for Public Queries	Name	Hiroki Irisuna
	Affiliation	FRONTEO Inc.
	Address	2-12-23 Konan, Minato-ku, Tokyo Japan
	Telephone	+81-80-4865-1308
	E-mail	hiroki_irisuna@fronteo.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 03, 2022
Actual date of first enrollment		Sept. 13, 2022
Target sample size		100
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1) Outpatient 2)Between 18 and 65 years of age at the time of consent and diagnosed with schizophrenia according to the DSM-5. 3)Who can obtain written consent from the person 4)Who speak Japanese as his/her mother tongue and able to have an interview (conversation with doctors and medical staff)
	Exclusion Criteria	1)Who has been judged by a doctor to have difficulty in having conversation due to deafness, dysarthria, aphasia, etc. 2)Who has been diagnosed of having a pyschiatric disorder such as depression 3)Who has been diagnosed of a dementia or judged to have cognitive dysfunction due to neurological diseases (epilepsy, stroke, etc.) 4)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 the signs of relapse for schizophrenic patient

Primary Sponsor	Sumitomo Pharma Co., Ltd.

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	Sept. 05, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 18, 2022	(this page)	Changes
1	Sept. 03, 2022	Detail

List of change history