UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039335 |
|---|---|
| Receipt number | R000044675 |
| Scientific Title | Multicenter investigation of reliability and validity of the Edinburgh Postnatal Depression Scale (EPDS) as a screening tool for depression during pregnancy |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2022/02/02 08:01:11 |
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Basic information
Public title
Multicenter investigation of reliability and validity of the Edinburgh Postnatal Depression Scale (EPDS) as a screening tool for depression during pregnancy
Acronym
Multicenter investigation of reliability and validity of the Edinburgh Postnatal Depression Scale (EPDS) as a screening tool for depression during pregnancy
Scientific Title
Multicenter investigation of reliability and validity of the Edinburgh Postnatal Depression Scale (EPDS) as a screening tool for depression during pregnancy
Scientific Title:Acronym
Multicenter investigation of reliability and validity of the Edinburgh Postnatal Depression Scale (EPDS) as a screening tool for depression during pregnancy
Region
| Japan |
Condition
Condition
perinatal depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of reliability and validity of Edinburgh Postnatal Depression Scale for the perinatal depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cut-off score
Key secondary outcomes
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
Female
Key inclusion criteria
Subjects who give consent in the participation
Key exclusion criteria
1. Subjects with a severe physical illness
2. Subjects who can't answer in japanese
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamashita |
Organization
Kyushu University Hospital
Division name
Department of Child Psychiatry
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5624
h-yama03@npsych.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Katsuki |
Organization
Kyushu University Hospital
Division name
Department of Child Psychiatry
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5624
Homepage URL
d.katsuki.a26@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Section of IRB & Ethics Committee Administration, Academic Research Support Division, Kyushu University Hospital
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
| 2020 | Year | 03 | Month | 31 | 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
234
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigation of reliability and validity of Edinburgh Postnatal Depression Scale for the perinatal depression
Management information
Registered date
| 2020 | Year | 01 | Month | 31 | Day |
Last modified on
| 2022 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044675
