UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051822 |
|---|---|
| Receipt number | R000059109 |
| Scientific Title | Post hoc analysis of web-based survey (ref. UMIN000048497) on emotional blunting in Japanese patients with Major Depressive Disorder |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2025/04/21 14:10:28 |
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Basic information
Public title
Post hoc analysis of web-based survey (ref. UMIN000048497) on emotional blunting in Japanese patients with Major Depressive Disorder
Acronym
Post hoc analysis of web-based survey (ref. UMIN000048497) on emotional blunting in Japanese patients with Major Depressive Disorder
Scientific Title
Post hoc analysis of web-based survey (ref. UMIN000048497) on emotional blunting in Japanese patients with Major Depressive Disorder
Scientific Title:Acronym
Post hoc analysis of web-based survey (ref. UMIN000048497) on emotional blunting in Japanese patients with Major Depressive Disorder
Region
| Japan |
Condition
Condition
Major depressive disorder (MDD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is
To determine the impact of EB on patients' depressive symptoms and social function.
To determine the patient background factors that affect EB on patients.
To examine EB and other MDD-related characteristics (Oxford Depression Questionnaire (ODQ), Patient Health Questionnaire-9 (PHQ-9) and subjective EB scores) from expressions used by patients.
Basic objectives2
Others
Basic objectives -Others
Data base research with Web-based questionnaire
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation of ODQ/ODQ sub-domain (General reduction (GR), Positive reduction (PR), Emotional detachment (ED), Not caring (NC), Antidepressant as cause (AC)) scores with Workand Social Adjustment Scale (WSAS)/WSAS sub-item scores and PHQ-9/PHQ-9 sub-item scores
Key secondary outcomes
Secondary Endpoint:
- Relationship between patient background factors and with/without gap between the degree of subjective EB symptoms and ODQ scores
Exploratory Endpoint:
- Contribution of ODQ subdomains to WSAS and PHQ-9 after adjusting for interrelationships among WSAS, PHQ-9 and ODQ
- Relationship between expressions used by patients and MDD -related characteristics (ODQ, PHQ-9 and subjective EB scores)
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The following subjects are eligible for the survey if they meet all of the following criteria:
(1) Aged between 18 and 59 years old (regardless of gender)
(2) Those who have been diagnosed with MDD.
(3) Those who have been taking antidepressant medication for at least three months.
(4) Those who have been visiting a hospital for more than three months.
(5) Those who can use the Internet with a personal computer, smartphone, or tablet.
(6) Those who can give consent online based on their own free will after understanding the explanation in Japanese.
Key exclusion criteria
The preliminary web-based questionnaire ask whether any of the following conditions are met, and those who meet the conditions are not eligible for the survey.
(1) Those who have been diagnosed with bipolar disorder.
(2) Those not currently taking antidepressants
Target sample size
3376
Research contact person
Name of lead principal investigator
| 1st name | Miwa |
| Middle name | |
| Last name | Izutsu |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3242-1256
keita.fujikawa@takeda.com
Public contact
Name of contact person
| 1st name | Fumie |
| Middle name | |
| Last name | Tokuda |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3242-1256
Homepage URL
fumie.tokuda@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Lundbeck Japan K.K.
Name of secondary funder(s)
Lundbeck Japan K.K.
IRB Contact (For public release)
Organization
Research Institute of Healthcare Data Science
Address
SumitomoShibadaimon building 12F, 5-5, Shibadaimon 2-chome, Minato-ku, Tokyo, Japan
Tel
03-5733-5010
rihds@jmdc.co.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 | 08 | Month | 07 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000059109
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/articles.php?article_id=102021
Number of participants that the trial has enrolled
3376
Results
The ODQ total score correlated moderately with WSAS (r=0.578) and strongly with PHQ-9 (r=0.670). Subdomains "not caring, NC" and "reduction in positive emotions, PR" strongly impacted WSAS and PHQ-9 scores. Men and unemployed individuals often underestimated EB severity relative to ODQ scores. Assessing NC and PR is critical for evaluating EB's impact on social functioning and depressive symptoms in MDD. Physicians should consider EB symptoms alongside patient backgrounds for personalized care.
Results date posted
| 2025 | Year | 04 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Data for this post hoc analysis were available for 3376 patients who completed our previously reported survey on EB in Japan. Patient characteristics have been described previously (Kikuchi T, Iga JI, Oosawa M, Hoshino T, Moriguchi Y, Izutsu M. A web-based survey on the occurrence of emotional blunting in patients with major depressive disorder in Japan: patient perceptions and attitudes. Neuropsychopharmacol Rep. 2024;44(2):321-332. doi:10.1002/npr2.12417).
Participant flow
Refer to (Kikuchi T, Iga JI, Oosawa M, Hoshino T, Moriguchi Y, Izutsu M. A web-based survey on the occurrence of emotional blunting in patients with major depressive disorder in Japan: patient perceptions and attitudes. Neuropsychopharmacol Rep. 2024;44(2):321-332. doi:10.1002/npr2.12417).
Adverse events
Not Applicable
Outcome measures
The primary endpoint of this post hoc analysis was the correlation between ODQ scores (total score and each subdomain score) and the total and individual domain/item scores of the WSAS and PHQ-9.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 08 | Month | 18 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 31 | Day |
Other
Other related information
The web-based survey (UMIN000048497) was conducted via the monitored patient panel. The survey was performed between 29 July and 9 August 2022.Potential participants who met the inclusion criteria were identified from the patient panel and invited to participate. Respondents were then provided with information about the
study before being screened for eligibility. At the beginning of the survey, participants were informed that they could refuse to answer any question and could withdraw at any point. Data were collected by means of a self completed online survey.
Management information
Registered date
| 2023 | Year | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059109
