Status:
COMPLETED
Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
Lead Sponsor:
Japan Science and Technology Agency
Collaborating Sponsors:
University of Toyama
Chiba University
Conditions:
Trauma
Posttraumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries.
Detailed Description
Accidental injuries, mostly motor vehicle accident, in civilian population are frequent events.For instance, nearly one-third of injured patients appear to develop trauma-related psychiatric illness a...
Eligibility Criteria
Inclusion
- 18 plus years
- A native Japanese speaking ability
- Possibility to contact patients with injury in 240 hours, and dosing in oral use
- Physical and metal status to possible understands scope and contents in the trial and gets informed consent
Exclusion
- Clearly irretrievable acute brain parenchyma damage and subdural or subarachnoidal bleeding detected by computed tomography and/or magnetic resonance imaging
- Cognitive impairment: Mini Mental State Examination \< 24
- Heavy drinker or 100IU/L ≦ γGTP in administration
- Heavy smoker (over 40 cigarettes per day)
- History and current suspicion in diagnosis of psychosis and bipolar I disorder
- Suspicion in diagnosis of alcoholic, substance-related disorder and eating disorder
- Existence of marked serious symptoms such as suicidal ideation, self-harm behavior, dissociation, status of need rapidly psychiatric treatment
- Use of anti-epilepsy drug, lithium, ethyl icosapentate and anti-coagulant drug (for example, aspirin, warfarin, etc) within 3 month at regular intervals
- Use of polyunsaturated fatty acid supplement within 3 month at regular intervals
- Habit of eating fish over 4 times per week
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00671099
Start Date
December 1 2008
End Date
December 1 2013
Last Update
January 22 2014
Active Locations (1)
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1
National Disaster Medical Center
Tachikawa, Tokyo, Japan, 1900014