UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045584 |
|---|---|
| Receipt number | R000052038 |
| Scientific Title | Development and validation of the Japanese version of EPDS-P for indirect screening of paternal perinatal depression based on maternal reporting: protocol for a prospective longitudinal observational study |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2024/10/20 15:03:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development and validation of the Japanese version of EPDS-P for indirect screening of paternal perinatal depression based on maternal reporting: protocol for a prospective longitudinal observational study
Acronym
Development and validation of the Japanese version of EPDS-P for indirect screening of paternal perinatal depression based on maternal reporting: protocol for a prospective longitudinal observational study
Scientific Title
Development and validation of the Japanese version of EPDS-P for indirect screening of paternal perinatal depression based on maternal reporting: protocol for a prospective longitudinal observational study
Scientific Title:Acronym
Development and validation of the Japanese version of EPDS-P for indirect screening of paternal perinatal depression based on maternal reporting: protocol for a prospective longitudinal observational study
Region
| Japan |
Condition
Condition
Paternal perinatal depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and validation of a screening system for paternal perinatal depression using the Japanese version of EPDS-P.
Basic objectives2
Others
Basic objectives -Others
Correlation between CES-D scores of men and EPDS-P scores based on report of women.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the following items at two points, third trimester in pregnancy and within 3 months after birth.
Men: CES-D
Women: EPDS-P
Key secondary outcomes
Men: EPDS
Women: EPDS, MIBS
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Perinatal women and male partner who give written consent to study participation
Key exclusion criteria
Under 20 years old / inability to understand the questionnaire written in Japanese / Those who withdraw their consent to participate in this study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Tokumitsu |
Organization
Dokkyo Medical University, School of Medicine
Division name
Department of Psychiatry
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
+81-282-86-1111
keitat@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Tokumitsu |
Organization
Dokkyo Medical University, School of Medicine
Division name
Department of Psychiatry
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
+81-282-86-1111
Homepage URL
keitat@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional review board of the ethics committee of the Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
Tel
+81-282-86-1111
kenkyu@dokkyomed.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
| 2021 | Year | 09 | Month | 30 | 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
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
CES-D: Center for Epidemiologic Studies Depression Scale
EPDS: Edinburgh Postnatal Depression Scale
EPDS-P: Edinburgh Postnatal Depression Scale -Partner
MIBS: Mother-Infant Bonding Scale
Management information
Registered date
| 2021 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052038
