臨床研究等提出・公開システム

Date of registration	Mar. 11, 2022
Last modified on	Feb. 20, 2026
Trial ID	jRCT1030210661

Scientific Title	Tree drawing test and drawing process
Public Title	Tree drawing test and drawing process

Contact for Scientific Queries	Name	Yumi Iwamitsu
	Affiliation	Kitasato University
	Address	1-15-1 Kitasato, Minami-ku, Sagamihara-shi
	Telephone	+81-42-778-7961
	E-mail	iyumi@kitasato-u.ac.jp
Contact for Public Queries	Name	Keita Kawasugi
	Affiliation	Tokaigakuen University
	Address	21-233 Nishinohora, Ukigai-cho, Miyoshi, Aichi,
	Telephone	+81-561-36-9708
	E-mail	kawasugi-k@tokaigakuen-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 11, 2022
Target sample size		230
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	factorial assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients 1. Schizophrenic patients (including schizophrenia-type disorder and delusional disorder) were diagnosed according to DSM5 (APA, 2013) at Tsuruga hospital. 2. The physicians determine that they are able to participate in this study. 3. All participants provided written consent to participate in this study. 4. The patients must be at least 20 years old. 5. The study will be conducted until the number of patients reaches 30 or more. (2) Healthy subjects Graduate students and staff from Kitasato University Graduate School of Medical Sciences who applied to participate in the research through poster postings and other means. Undergraduate and graduate students from the School of Letters, Arts and Sciences at Waseda University applied to participate through lectures taught by research collaborators and through emails sent on campus seeking research subjects. There were 200 healthy subjects, including 30 healthy adults needed to match the patient group in age.
	Exclusion Criteria	the physicians determine that schizophrenic patients cannot participate in this study
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		schizophrenia (including schizophrenia-type disorders and delusional disorders)
Intervention(s)		1. Puzzle task 2. Baum Test 3. Figure division Task 4. Comments on tasks 1 to 3 5. Brief Assessment of Cognition in Schizophrenia (BACS) Japanese version 6.Schizotypal Personality Scale 7. Self-Rating Depression Scale 8.Other questions such as demographic data
Primary Outcome(s)		1. Puzzle task 2. Baum Test 3. Figure division Task 5. Brief Assessment of Cognition in Schizophrenia (BACS) Japanese version 6.Schizotypal Personality Scale (healthy Group) 7. Self-Rating Depression Scale (healthy Group)
Secondary Outcome(s)		4. Comments on tasks 1 to 3 (required time: about 5 minutes) 8. Other questions such as demographic data

Primary Sponsor	Kitasato University

Secondary Sponsor

Secondary Sponsor	Not applicable

Name of Certified Review Board	The Institutional review board at Kitasato University School of Allied Health Science
Address	1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Telephone	+81-42-778-9757
E-Mail	kenkyu@kitasato-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 13, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Feb. 20, 2026	(this page)	Changes
1	Mar. 11, 2022	Detail

List of change history