UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between abilities to clean up and cognitive functions in outpatients with psychiatric disorders
Acronym	The relationship between abilities to clean up and cognitive functions in outpatients with psychiatric disorders
Scientific Title	The relationship between abilities to clean up and cognitive functions in outpatients with psychiatric disorders
Scientific Title:Acronym	The relationship between abilities to clean up and cognitive functions in outpatients with psychiatric disorders
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to explore the relationship between severities of squalor syndrome, psychiatric symptoms, cognitive functions, and brain morphologies in patients with schizophrenia.
Basic objectives2	Others
Basic objectives -Others	To elucidate the pathology of squalor syndrome in patients with schizophrenia
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Environmental Cleanliness and Clutter Scale, Clutter Image Rating Scale by observers
Key secondary outcomes	GAF: Global Assessment of Functioning, PANSS: Positive and Negative Syndrome Scale, SCI: Saving Cognitions Inventory, The Elgin Behavioral Rating Scale, The Brief Assessment of Cognition in Schizophrenia, Dimensional Yale-Brown Obsessive-Compulsive Scale, Hoarding Rating Scale, Saving Inventory Revised, Saving Cognitions Inventory, Clutter Image Rating Scale by self rated, Life Skills Profile, brain morphology in 3D T1 MRI

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	1) Subjects who meet the DSM-5 criteria of schizophrenia spectrum disorders and other psychotic disorders 2) Subjects whose rooms are observable by medical staff 3) Subjects who can provide written informed consent 4) Subjects who can take cognitive tests and questionnaire tests
Key exclusion criteria	1) Subjects who tend to suicide or do self-harm 2) Subjects with a severe physical complication 3) Subjects who are considered to be inappropriate to participate in the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Koreki
Organization	National Hospital Organization Shimofusa Psychiatric Medical Center
Division name	Department of Psychiatry
Zip code	266-0007
Address	578 Heta, Midori-ku, Chiba-city, Chiba, 266-0007, Japan
TEL	0432911221
Email	koreki.akihiro.th@mail.hosp.go.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Koreki
Organization	National Hospital Organization Shimofusa Psychiatric Medical Center
Division name	Department of Psychiatry
Zip code	266-0007
Address	578 Heta, Midori-ku, Chiba-city, Chiba, 266-0007, Japan
TEL	0432911221
Homepage URL
Email	koreki.akihiro.th@mail.hosp.go.jp

Sponsor
Institute	National Hospital Organization Shimofusa Psychiatric Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Shimofusa Psychiatric Medical Center
Address	578 Heta, Midori-ku, Chiba-city, Chiba, 266-0007, Japan
Tel	0432911221
Email	motoyoshi.yuji.mf@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 18 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	2021 Year 06 Month 25 Day
Date of IRB	2021 Year 09 Month 24 Day
Anticipated trial start date	2021 Year 10 Month 18 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	Assessments of clinical symptoms: GAF, PANSS,The Elgin Behavioral Rating Scale, The Brief Assessment of Cognition in Schizophrenia, Dimensional Y-BOCS, Hoarding Rating Scale, Saving Inventory Revised, Saving Cognition Inventory, CIRS, Life Skills Profile 3D T1 MRI of the head

Management information
Registered date	2021 Year 10 Month 17 Day
Last modified on	2021 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052174