UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057917 |
|---|---|
| Receipt number | R000065964 |
| Scientific Title | Cross-sectional Web Survey on the Burdens Faced by Individuals with Bipolar Disorder |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/12/03 19:04:42 |
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Basic information
Public title
Cross-sectional Web Survey on the Burdens Faced by Individuals with Bipolar Disorder
Acronym
Web Survey on the Burdens Faced by Individuals with Bipolar Disorder
Scientific Title
Cross-sectional Web Survey on the Burdens Faced by Individuals with Bipolar Disorder
Scientific Title:Acronym
Web Survey on the Burdens Faced by Individuals with Bipolar Disorder
Region
| Japan |
Condition
Condition
bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the burdens and distressing symptoms faced by individuals with bipolar disorder in their daily lives
Basic objectives2
Others
Basic objectives -Others
Investigations of burdens in daily life
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Current burdens in daily life
Key secondary outcomes
- Current distressing psychiatric symptoms
- State of depressive symptoms
- State of manic symptoms
- State of cognitive function
- Sleep-related issues
- State of anxiety symptoms
- Employment/education status
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects aged between 18 and 65 at the time of informed consent
2. Subjects diagnosed with bipolar disorder by a physician
3. Subjects who have visited an outpatient clinic for the treatment of bipolar disorder within the last three months
4. Subjects who have read and fully understood the web-based instructions for participating in the survey, and who have voluntarily agreed to answer the questionnaire.
Key exclusion criteria
Subjects who have been diagnosed with schizophrenia or dementia at the time of participating in the study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Tadafumi |
| Middle name | |
| Last name | Kato |
Organization
Juntendo University
Division name
Department of Psychiatry, Faculty of Medicine
Zip code
113-8421
Address
Hongo 2-1-1, Bunkyo
TEL
03-3813-3111
tadafumi.kato@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Haoka |
Organization
3H Medi Solution Inc.
Division name
Contact point for web survey on burdens faced by individuals with bipolar disorder
Zip code
171-0022
Address
JRE Minami-Ikebukur Bldg. 2F, 1-13-23, Minami-Ikebukuro, Toshima-ku, Tokyo, Japan
TEL
0120-386-600
Homepage URL
fact_survey@3h-ms.co.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
2-1-1, Hongo,Bunkyo-ku,Tokyo
Tel
03-3813-3111
hongo-rinri@juntendo.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
| 2025 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
625
Results
A web-based survey was conducted among individuals aged 18 - 64 diagnosed with bipolar disorder. This study was approved by the Ethics Committee of Juntendo University, and informed consent was obtained from participants. Of the 625 respondents, 516 were included in the analysis. Overall, 96.5% experienced some difficulty in daily living functions, with financial management being the most common. Symptom-related difficulties most frequently reported included sleep problems, anxiety, and cognitive function.
Results date posted
| 2025 | Year | 12 | Month | 03 | Day |
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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2025 | Year | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065964
