UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051519 |
|---|---|
| Receipt number | R000058770 |
| Scientific Title | Associations between cognitive function and work productivity in bipolar disorder patients: An observational study. |
| Date of disclosure of the study information | 2023/07/04 |
| Last modified on | 2026/08/18 09:48:29 |
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Basic information
Public title
Associations between cognitive function and work productivity in bipolar disorder patients: An observational study.
Acronym
Associations between cognitive function and work productivity in bipolar disorder patients: An observational study.
Scientific Title
Associations between cognitive function and work productivity in bipolar disorder patients: An observational study.
Scientific Title:Acronym
Associations between cognitive function and work productivity in bipolar disorder patients: An observational study.
Region
| Japan |
Condition
Condition
Bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to conduct a questionnaire survey of patients with bipolar disorder to prospectively assess work productivity, work status, and medical treatment status and to reveal their relationship with cognitive function.
Basic objectives2
Others
Basic objectives -Others
Correlation between change in cognitive function and work productivity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in cognitive function and work productivity from baseline to 48 weeks
Key secondary outcomes
(1) Change in cognitive function and each assessment index (from baseline to the time of each assessment)
(2) Change in each assessment index in the improved cognitive function group and the worsened or unchanged cognitive function group at 12 weeks after baseline (from 12 weeks to the time of each assessment)
(3) Change in each assessment index in the mild cognitive disfunction group and the moderate to severe cognitive disfunction group at baseline (from baseline to each time of assessment)
(4) Change in each assessment index in the mild cognitive disfunction group and the moderate to severe cognitive disfunction group at 12 weeks after baseline (from 12 weeks to the time of each assessment)
(5) Cognitive function and each assessment index at baseline
(6) Patient background at baseline
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Bipolar patients registered with QLife attending a medical institution at the time of the first questionnaire survey
2.Patients aged 18 years or more and under 60 years at the time of informed consent
3.Patients who are employed or on temporary retirement
4.Patients who are able to complete the questionnaire via the website at the time of assessment
5.Patients who have given their consent to participate in this study
Key exclusion criteria
1.Patients who do not plan to return to work or find employment in the next one year
2.Hospitalized patients
3.Patients diagnosed with dementia
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Takaesu |
Organization
University of the Ryukyus
Division name
Department of Neuropsychiatry, Graduate School of Medicine
Zip code
903-0215
Address
207 Aza-Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
TEL
098-895-1157
takaesuy@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Mebix, Inc.
Division name
Patient Outcome Team, Medical Science & Writing Group
Zip code
105-0001
Address
Toranomonn 33 Mori Bld.10F 3-8-21Toranomon Minato-ku Tokyo Japan
TEL
0120-37-4089
Homepage URL
clinical-research-dmq23@m3.com
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Yoshikazu Takaesu
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
Ethics Review Committee for Life Sciences and Medical Research Involving Human Subjects, University of the Ryukyus
Address
207 Aza-Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
Tel
098-895-1543
krinken@acs.u-ryukyu.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
| 2023 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/npr2.70036
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/npr2.70036
Number of participants that the trial has enrolled
211
Results
There was a weak correlation between change in cognitive impairment and change in presenteeism from baseline to Week 48 (Pearson R=0.304, p=0.001), but the multiple regression analysis showed no association.
Change in presenteeism was significantly associated with change in depressive symptoms (regression coefficient=2.43, p<0.001).
Change in QOL was significantly associated with change in insomnia (regression coefficient=-0.01, p<0.05).
Results date posted
| 2026 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Briefly, the mean age was 38.9 years, 64.9% were female, 41.2% were working full time, and 40.3% had comorbidities.
Cognitive impairment (COBRA > 14) was present in 59.7% of participants, and depressive symptoms (PHQ-9>=10) were present in 67.8% of participants.
The mean WPAI-GH presenteeism was 45.1%, the mean indirect cost was 1688.0 thousand Japanese yen, and the mean QOL utility value (HUI3) was 0.461.
Participant flow
Of the 353 participants with bipolar disorder who provided electronic informed consent and were enrolled in the study, 211 were included in the analysis population of the overall study.
The 48-week longitudinal analysis included 179 participants who responded to all study questionnaires for up to 48weeks (i.e., the study duration).
Adverse events
Not applicable.
Outcome measures
The primary endpoint was the correlation between change from baseline at 48 weeks in cognitive impairment and work productivity loss (presenteeism, absenteeism, overall work impairment, and activity impairment).
The secondary endpoints included change from baseline in each assessment scale score: cognitive impairment, depressive symptoms, sleep disturbance (ESS and AIS), work productivity loss (presenteeism, absenteeism, overall work impairment, activity impairment), and QOL (HUI3).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Correlation between change in cognitive function and work productivity.
Management information
Registered date
| 2023 | Year | 07 | Month | 04 | Day |
Last modified on
| 2026 | 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=R000058770
