UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037844 |
|---|---|
| Receipt number | R000043132 |
| Scientific Title | Brain imaging using the score of the Japanese version of Edinburgh Depression Scale and MRI as screening for postpartum depression |
| Date of disclosure of the study information | 2019/08/29 |
| Last modified on | 2021/03/01 23:39:06 |
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Basic information
Public title
Brain imaging using the score of the Japanese version of Edinburgh Depression Scale and MRI as screening for postpartum depression
Acronym
Brain imaging for postpartum depression
Scientific Title
Brain imaging using the score of the Japanese version of Edinburgh Depression Scale and MRI as screening for postpartum depression
Scientific Title:Acronym
Brain imaging for postpartum depression
Region
| Japan |
Condition
Condition
mothers who had delivered at the Iwate Medical University Hospital
Classification by specialty
| Obstetrics and Gynecology | Psychiatry | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)Exploring the mechanism of postpartum depression by diffusion MRI
2)To verify whether diffusion MRI can be applied as a new diagnostic method for postpartum depression
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Psychiatric assessment for PPD from 1 to 2 months postpartum
2)Imaging MRI one month after delivery and comparing between postpartum depression group and normal group
3)Compare diagnostic accuracy of MRI and EPDS
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Mothers who had delivered at the Iwate Medical University Hospital
2)Patients who had provided written informed consent
Key exclusion criteria
1) MRI contraindication
2) history of mental disorder including depression or intracranial organic abnormality,
3) stillbirth delivery
4) possibly be subjected to mental, physical or social burden by participating in the study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Oyama |
Organization
Iwate Medical University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
0208505
Address
19-1 Uchimaru, Morioka, Iwate
TEL
019-651-5111
oyamarie@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Sasaki |
Organization
Iwate Medical University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
0208505
Address
19-1 Uchimaru, Morioka, Iwate
TEL
019-651-5111
Homepage URL
yurisasa@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Strategic Medical Science Research from the Ministry of Education Culture, Sports, Science, and Technology of Japan
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
Iwate Medical University School of Medicine
Address
19-1 Uchimaru, Morioka, Iwate
Tel
019-651-5111
kenkyu-rinri@j.iwate-med.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
| 2019 | Year | 08 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-020-72310-1
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-020-72310-1
Number of participants that the trial has enrolled
89
Results
In the PPD group, FA values in the white matter and thalamus were significantly lower and MD values in the white matter and putamen were significantly higher. The area with significant differences in MD value was more extensive (40.8%) than the area with significant differences in FA value (6.5%). These findings may reflect pathophysiological differences of PPD compared with MDD.
Results date posted
| 2021 | Year | 03 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible patients in the study were mothers who had delivered at the Iwate Medical University Hospital
Participant flow
Eligible patients underwent an MRI at 1 month postpartum and a psychiatric assessment for PPD within 2 months postpartum (within 1 month of the MRI).
Adverse events
N/A
Outcome measures
To identify changes in the whole-brain white matter between the PPD and non-PPD groups, we carried out voxel-wise statistical analysis of the MK, FA, and MD maps using tract-based spatial statistics (TBSS)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 29 | Day |
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2019 | Year | 08 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043132
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