UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055272 |
|---|---|
| Receipt number | R000062862 |
| Scientific Title | Validity and reliability of the Japanese version of the Functional Assessment Test (FAST/FASTO) in Bipolar Disorder |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/08/18 08:08:24 |
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Basic information
Public title
Validity and reliability of the Japanese version of the Functional Assessment Test (FAST/FASTO) in Bipolar Disorder
Acronym
Validity and reliability of the Japanese version of the Functional Assessment Test (FAST/FASTO) in Bipolar Disorder
Scientific Title
Validity and reliability of the Japanese version of the Functional Assessment Test (FAST/FASTO) in Bipolar Disorder
Scientific Title:Acronym
Validity and reliability of the Japanese version of the Functional Assessment Test (FAST/FASTO) in Bipolar Disorder
Region
| Japan |
Condition
Condition
Bipolar disorder patients and Healthy individuals without psychiatric disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the reliability and validity of the Japanese versions of the Functioning Assessment Short Test (FAST) and Functioning Assessment Short Test for Older adults (FASTO), which were developed for the clinical assessment of functional impairment in bipolar disorder patients, in bipolar disorder patients and healthy individuals without psychiatric disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The reliability of FAST (FASTO), SOFAS, and SDS will be compared between the first and second evaluation scores using correlation coefficients .
The internal consistency (validity) of FAST (FASTO) will be evaluated by calculating Cronbach's alpha coefficient .
Key secondary outcomes
To verify correlation coefficients between functional impairment in bipolar patients, such as increases in FAST (FASTO), and the severity of clinical symptoms.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
Bipolar patients
Interventions/Control_2
Healthy volunteers
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria Those who meet all of the following criteria will be included in the study.
[All subjects]
Age: 20-90 years for FAST, 50-90 years for FASTO who are not employed.
Gender does not matter.
Subjects who have fully understood the purpose of the study and given written consent after receiving a written explanation approved in advance by Saitama Medical University Hospital IRB (hereafter referred to as the Hospital IRB), as well as a sufficient oral explanation.
Restrictions on concomitant medications: None [Bipolar Disorder Patients] Patients who visited the Neuropsychiatry and Psychosomatic Medicine Department of Saitama Medical University Hospital and were invited to participate by the principal investigator or researcher, and patients who applied voluntarily after seeing a poster or other recruitment notice.
Patients who meet the diagnostic criteria for bipolar disorder based on the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5-TR) created by the American Psychiatric Association.
Inpatient or outpatient care is not required.
Diagnosis is made by clinical diagnostic interview and the Mini International Neuropsychiatric Interview (MINI).
Screening is performed by clinical interview and structured interview MINI.
Medication is not required. [Healthy Subjects] Patients who applied voluntarily after seeing a poster or other notice.
Those who are not found to have a neurological or psychiatric disorder by clinical interview and MINI.
Key exclusion criteria
Those who meet any of the following criteria will be excluded from this study.
[All subjects]
Individuals with an IQ below 70 or an equivalent educational background (e.g., graduating from a special needs school).
Individuals with low cognitive function (Mini Mental Statement Examination (MMSE) < 18).
Other individuals who the researcher deems unsuitable as subjects, such as those with extremely unstable mental symptoms (e.g., those who have repeatedly attempted suicide).
[Healthy subjects]
Individuals diagnosed with a mental illness in the MINI.
ndividuals with a first-degree blood relative with a mental illness.
Individuals with a history of continuous use of antipsychotics or antidepressants.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hisatoshi |
| Middle name | |
| Last name | Arai |
Organization
Saitama Medical University Hospital
Division name
Department of Psychiatry
Zip code
350-0495
Address
38 Morohongo Moroyama-machi,iruma-gun,saitama
TEL
0492761214
harai@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hisatoshi |
| Middle name | |
| Last name | Arai |
Organization
Saitama Medical University Hospital
Division name
Department of Psychiatry
Zip code
350-0495
Address
38 Morohongo Moroyama-machi,iruma-gun,saitama
TEL
0492761214
Homepage URL
harai@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Hisatoshi Arai
Funding Source
Organization
others
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
Saitama Medical University Hospital IRB
Address
38 Morohongo Moroyama-machi,iruma-gun,saitama
Tel
0492761111
http://www.saitamamed.ac.jp/hospital/outline/irb.html
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
| 2024 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2004 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 18 | Day |
Last modified on
| 2024 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062862
