UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047781 |
|---|---|
| Receipt number | R000054472 |
| Scientific Title | Elucidation of biological mechanisms of pathological grief in a longitudinal investigation |
| Date of disclosure of the study information | 2022/05/17 |
| Last modified on | 2024/06/28 21:55:31 |
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Basic information
Public title
Understaning of mechanisms in coping with grief after bereavement
Acronym
Mechanisms in coping with grief
Scientific Title
Elucidation of biological mechanisms of pathological grief in a longitudinal investigation
Scientific Title:Acronym
Biological mechanisms of grief
Region
| Japan |
Condition
Condition
Prolonged grief disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Pathological factors
Basic objectives2
Others
Basic objectives -Others
Etiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain functional and structural imaging measures
Key secondary outcomes
Salivary inflammatory markers, salivary oxytocin concentration, oxytocin receptor DNA methylation polymorphism, heart rate variability, physical activity, grief symptoms, depression symptoms, anxiety symptoms, posttraumatic stress symptoms, quality of life, sleep quality, daytime sleepiness, pain empathy, attachment style, post-traumatic growth
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
1) Aged 20 years or older
2) Bereaved of a significant other (a family member, relative, friend, or partner)
3) Bereaved for more than 12 months
4) Capable to provide informed consent
5) MRI indicated
Key exclusion criteria
1) Any psychiatric disorders excluding prolonged grief disorder, depressive disorders, posttraumatic stress disorder, or anxiety disorders
2) Substance-related disorders within 6 months
3) Self-harm or suicide attempt within 6 months
4) A score less than 24 on Mini-Mental State Examination
5) Neurological disorders
6) Pregnancy
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Yoshiike |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo
TEL
042-346-2071
yoshiike@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Yoshiike |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo
TEL
042-346-2071
Homepage URL
https://sites.google.com/view/pgdbiostudy/
yoshiike@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
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
Ethical Committee of National Center of Neurology and Psychiatry
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo
Tel
042-346-2071
rinri-jimu@ncnp.go.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
| 2022 | Year | 05 | Month | 17 | 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
| 2022 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 05 | Month | 17 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054472
