UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060615 |
|---|---|
| Receipt number | R000069330 |
| Scientific Title | Clinical Characteristics of Functional Impairment in Bipolar Disorder and Depression Using the Functional Assessment Short Test (FAST) |
| Date of disclosure of the study information | 2026/03/03 |
| Last modified on | 2026/02/08 12:06:38 |
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Basic information
Public title
Clinical Characteristics of Functional Impairment in Bipolar Disorder and Depression Using the Functional Assessment Short Test (FAST)
Acronym
Clinical Characteristics of Functional Impairment in Bipolar Disorder and Depression Using the Functional Assessment Short Test (FAST)
Scientific Title
Clinical Characteristics of Functional Impairment in Bipolar Disorder and Depression Using the Functional Assessment Short Test (FAST)
Scientific Title:Acronym
Clinical Characteristics of Functional Impairment in Bipolar Disorder and Depression Using the Functional Assessment Short Test (FAST)
Region
| Japan |
Condition
Condition
Bipolar disorder /Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the characteristics and differences in functional impairment associated with each disorder by using the FAST (Functioning Assessment Short Test), developed for the clinical assessment of functional impairment, in subjects with bipolar disorder, depression, and healthy individuals without mental illness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
This study compares individuals with bipolar disorder, depression, and healthy controls using the FAST assessment, focusing primarily on its sub-items.
The aim is to clarify the characteristics and differences in functional impairments associated with each disorder.
Key secondary outcomes
Evaluate the severity of functional impairments in bipolar disorder and depression.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Bipolar disorder/Depression
Patients who were invited to participate by the principal investigator or study coordinator among those who visited the Department of Neuropsychiatry and Psychosomatic Medicine at Saitama Medical University Hospital and its affiliated research institutions, and patients who voluntarily applied after seeing recruitment posters or similar materials.Patients meeting the diagnostic criteria for bipolar disorder and depression based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition: DSM-5-TR, developed by the American Psychiatric Association.Inpatient or outpatient care is not restricted.Diagnosis is made based on clinical diagnostic interviews and the MINI (Mini International Neuropsychiatric Interview).Screening is conducted using clinical interviews and the MINI structured interview.Regardless of whether medication is administered.
Healthy people
Among those who voluntarily applied after seeing posters, etc., Individuals for whom no neurological or psychiatric disorders are identified through clinical interviews and MINI.
Key exclusion criteria
All subjects
Individuals with an IQ below 70 and equivalent educational background (e.g., graduation from a special needs school).Individuals with low cognitive functioning (Mini Mental State Examination (MMSE) score < 18). Other cases where the research staff deems the subject unsuitable, such as when mental symptoms are highly unstable (e.g., repeated suicide attempts).
Healthy people
Individuals diagnosed with a mental disorder.Individuals with a first-degree relative who has a mental disorder.Individuals with a history of continuous oral administration of antipsychotic or antidepressant medications.
Target sample size
90
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 Neuropsychiatry and Psychosomatic Medicine
Zip code
3500495
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 Neuropsychiatry and Psychosomatic Medicine
Zip code
3500495
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
Department of Neuropsychiatry and Psychosomatic Medicine
Hisatoshi Arai
Institute
Department
Personal name
Hisatoshi Arai
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Maruki Memorial Welfare Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University IRB
Address
38 Morohongo,Moroyama-Machi,Iruma-gun,Saitama
Tel
0492761111
harai@saitama-med.ac.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
| 2026 | Year | 03 | Month | 03 | 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
Primary Endpoint
This study compares individuals with bipolar disorder, depression, and healthy controls using the FAST assessment, focusing primarily on its sub-items.
The aim is to clarify the characteristics and differences in functional impairments associated with each disorder.
Secondary Evaluation Items
Evaluate the severity of functional impairments in bipolar disorder and depression.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Significance of the Research
This study, conducted at the Department of Neuropsychiatry and Psychosomatic Medicine at Saitama Medical University Hospital (hereinafter referred to as our hospital), utilizes FAST to clarify the characteristics and differences in functional impairments specific to bipolar disorder, depression, and healthy individuals without psychiatric disorders. By clarifying the functional impairments associated with each disorder, this study may contribute to the evaluation of interventions aimed at rehabilitation and functional enhancement for psychiatric disorders. It is also expected to provide valuable data for pharmacological and psychosocial interventions targeting the functional abilities of psychiatric patients.
Management information
Registered date
| 2026 | Year | 02 | Month | 08 | Day |
Last modified on
| 2026 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069330
