UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036645 |
|---|---|
| Receipt number | R000041744 |
| Scientific Title | The relationship between blood unsaturated fatty acid and Post-traumatic stress disorder |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2023/11/06 15:16:49 |
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Basic information
Public title
The relationship between blood unsaturated fatty acid and Post-traumatic stress disorder
Acronym
The relationship between blood unsaturated fatty acid and Post-traumatic stress disorder
Scientific Title
The relationship between blood unsaturated fatty acid and Post-traumatic stress disorder
Scientific Title:Acronym
The relationship between blood unsaturated fatty acid and Post-traumatic stress disorder
Region
| Japan |
Condition
Condition
trauma
Classification by specialty
| Psychiatry | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze associations The ratio of blood Omega-3 fatty acid and Omega-6 fatty acid of patients with trauma and PTSD symptom, Psychiatric symptoms of depression and anxiety and Association of the quality of life (QOL).
Basic objectives2
Others
Basic objectives -Others
analyze associations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We measure the Omega-3/Omega-6 ratio from the fatty acid fractionation of the blood sample.Using three following questions paper list,we evaluate a PTSD symptom,psychiatric symptoms,quality of life of depression and the anxiety.:1)PDS(PTSD Diagnostic Scale;Itoh et al.,2017) 2)HADS(Hospital Anxiety and Depression Scale;Zigmond et al.,1993) 3)WHO-QOL26(WHO Quality of Life 26; Tazakiļ½„Nakane, 1997)
Key secondary outcomes
We measure EPA,DHA,DPA,ALA included in Omega-3 system fatty acid, LA,AA included in Omega-6 system fatty acid from a blood sample. We obtain the following items from a medical record and the ambulance conveyance record.:age, sex, heart rate on admission, state of consciousness at admission, physical trauma severity, the injury situation development time,attribute of the injury situation, laboratory findings, vital signs at hospital conveyance, initial treatment at conveyance, the medication situation.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Study participants shall satisfy following all the following criteria
1)The patients who were conveyed in Kitasato University Hospital because of trauma and became the hospitalization
2)The patients from 18 years old to 69 years old
3)When agreements from the family of the person or the person to this study participation are obtained after hospitalization
Key exclusion criteria
When study patients meet the following criteria more than one, we exclude it.
1)When an organic cerebral parenchyma disorder is found in examination for brain imaging (CT/MRI)
2)Patients have a diagnosis of schizophrenia or mood disorders or epilepsy or Neurodegenerative disease. Patients with a history of other mental disorder
3)When a mental or physical state is poor so as not to be able to tolerate an investigation
4)Patients to assume a native language anything other than Japanese
5)When there is an offer of cancellation from the person or the family of the person to this study participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Miyaoka |
Organization
Kitasato University
Division name
Department of Psychiatry
Zip code
252-0375
Address
1-15-1 Kitasato,Minami-ku, Sagamihara-shi, Kanagawa, Japan
TEL
042-778-8111
miyaoka@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Inoue |
Organization
Kitasato University
Division name
Department of Psychiatry
Zip code
252-0375
Address
1-15-1 Kitasato,Minami-ku, Sagamihara-shi, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
dm18002@st.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Kitasato University Medical Ethics Organization(KMEO)
Address
1-15-1 Kitasato,Minami-ku, Sagamihara-shi, Kanagawa, Japan
Tel
042-778-8111
rinri@med.kitasato-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
| 2019 | Year | 06 | Month | 01 | 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
| Delay expected |
Results Delay Reason
This was due to a delay in collecting cases due to refraining from contact with patients due to infection control measures due to COVID-19 pandemic.
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective case series study
Management information
Registered date
| 2019 | Year | 05 | Month | 03 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041744
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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