Tokyo, March 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060615) titled 'Clinical Characteristics of Functional Impairment in Bipolar Disorder and Depression Using the Functional Assessment Short Test (FAST)' on March 3.
Study Type:
Observational
Primary Sponsor:
Institute - Saitama Medical University Hospital
Department of Neuropsychiatry and Psychosomatic Medicine
Hisatoshi Arai
Condition:
Condition - Bipolar disorder /Depression
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 20
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 Size - 90
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 31 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069330
Disclaimer: Curated by HT Syndication.