臨床研究等提出・公開システム

Date of registration	April. 27, 2020
Last modified on	April. 28, 2021
Trial ID	jRCT1080225178

Scientific Title	A observational study using a wearable device for patients with schizophrenia
Public Title	A observational study using a wearable device in patients with schizophrenia

Completion Date or Terminated date	Nov. 25, 2020
Actual Enrolled Number	20
Baseline Characteristics	The proportion of men was 50.0% and 70.0% in A group and B group (same order hereunder), respectively. The mean (standard deviation [SD]) age was 45.3 (10.35) and 44.2 (11.61).
Participant flow	20 subjects were randomized to A group (10 subjects) and B group (10 subjects). No subject was discontinued.
Adverse events	Insomnia was observed in one subject in B group.
Primary Outcome Measures	The conseqtive days (mean) of wearing devices were 9.8 days and 3.4 days in A group and B group (same order hereunder) respectively. The rate (mean) of wearing the devices for each device were 79.6% and 36.3%.
Secondary Outcome Measures	No significant differences between baseline and endpoint were observed in number of steps, sleep time, CGI-S score or BRPS total score.
Brief summary	20 subjects were randomized to A group (10 subjects) and B group (10 subjects). The conseqtive days (mean) of wearing devices were 9.8 days and 3.4 days in A group and B group (same order hereunder) respectively. The rate (mean) of wearing the devices for each device were 79.6% and 36.3%.
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Sumitomo Dainippon Pharma Co., Ltd
	Address
	Phone Number
	E-mail Address	cc@ds-pharma.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Sumitomo Dainippon Pharma Co., Ltd
	Address
	Phone Number
	E-mail Address	cc@ds-pharma.co.jp

Recruitment Status	completed

Date of First Enrolment		June. 03, 2020
Target Sample Size		20
Study Type		Observational
Study Design	Study Design	Simple randomized, multi-center, open-label study
Study Design	Objective	other
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Inclusion Criteria: (1) Subjects who voluntarily provide written consent to participate in the study. If the subject is considered a minor at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject. (2) Subject who has schizophrenia diagnosed by DSM-5, diagnostic criteria, and in the opinion of the Investigator has been clinically stable. (3) Subject who has CGI-S score>=3 at baseline.
	Exclusion Criteria	Exclusion Criteria (1) Subjects who has DSM-5 diagnosis consistent with a DSM-5 diagnosis other than schizophrenia.
	Minimum Age	18age old over
	Maximum Age	65age old under
	Gender	Both
Health Condition or Problem Studied		schizophrenia
Intervention(s)		investigational material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : - control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		other The conseqtive days of wearing the devices and the rate of wearing the devices for each devices
Secondary Outcome		other Change of the number of steps Sleep activity Questionnaire to patients CGI-S BPRS

Primary Sponsor	Sumitomo Dainippon Pharma Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name	Sumitomo Dainippon Pharma Co., Ltd, Research Ethics Review Committee
Address	6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka 541-0045, Japan
Phone Number
E-mail Address
Status of Review	Approval
Date of Approval	Mar. 27, 2020

Name	Yoyogi Mental Clinic Research Ethics Committee
Address	3F,4-26-11 Sendagaya,Shibuya-ku,Tokyo 151-0051 Japan
Phone Number	+81-3-6804-2227
E-mail Address
Status of Review	Approval
Date of Approval	Mar. 27, 2020

Secondary ID No.	JapicCTI-205274
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
3	April. 28, 2021	(this page)	Changes
2	Aug. 26, 2020	Detail	Changes
1	April. 28, 2020	Detail

List of change history