UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045778 |
|---|---|
| Receipt number | R000052174 |
| Scientific Title | The relationship between abilities to clean up and cognitive functions in outpatients with psychiatric disorders |
| Date of disclosure of the study information | 2021/10/18 |
| Last modified on | 2021/10/17 18:09:02 |
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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
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
koreki.akihiro.th@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Shimofusa Psychiatric Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052174
