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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036645
Receipt No. 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 2019/07/13

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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
Email 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
Email dm18002@st.kitasato-u.ac.jp

Sponsor
Institute Kitasato University hospital
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2019 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2020 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 03 Day
Last modified on
2019 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041744

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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