Trial | NCT00671489  Report issue

Title

Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study
Phase 2 Study of Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    icosapent ethyl ...

  • Study Participants

    15
The purpose of this study is to evaluate the efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries.
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 and the major diagnoses are post-traumatic stress disorder (PTSD) and depressive disorder. Omega-3 Polyunsaturated Fatty Acid (Omega-3 PUFA) has some evidence of efficacy of treatment in patients with anxiety and mood disorders, but no evidence of preventing anxiety and mood disorders that occur subsequent to accidental injuries. We evaluate efficacy and safety of Omega-3 PUFA for the secondary prevention of Posttraumatic Stress Disorder (PTSD) and related psychiatric illness in patients with accidental injury.
Study Started
May 31
2008
Primary Completion
Feb 28
2009
Study Completion
Feb 28
2009
Last Update
Jul 03
2012
Estimate

Dietary Supplement Omega-3 Polyunsaturated Fatty Acid

A capsule of omega-3 Polyunsaturated Fatty Acid, 300mg (including 70% docosahexaenoic acid, 7% eicosapentaenoic acid and other), 7 capsules per day in 12 week.

Criteria 

Inclusion Criteria:

18 plus years
A native Japanese speaking ability
Possibility 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 Criteria:

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
No Results Posted