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

Phase 1/Phase 2
18 Years
Not Enrolling
Trauma, Posttraumatic Stress Disorder

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Trial Information

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

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.

Inclusion Criteria:

1. 18 plus years

2. A native Japanese speaking ability

3. Possibility contact patients with injury in 240 hours, and dosing in oral use

4. Physical and metal status to possible understands scope and contents in the trial and
gets informed consent

Exclusion Criteria:

1. Clearly irretrievable acute brain parenchyma damage and subdural or subarachnoidal
bleeding detected by computed tomography and/or magnetic resonance imaging

2. Cognitive impairment: Mini Mental State Examination < 24

3. Heavy drinker or 100IU/L ≦ γGTP in administration

4. Heavy smoker (over 40 cigarettes per day)

5. History and current suspicion in diagnosis of psychosis and bipolar I disorder

6. Suspicion in diagnosis of alcoholic, substance-related disorder and eating disorder

7. Existence of marked serious symptoms such as suicidal ideation, self-harm behavior,
dissociation, status of need rapidly psychiatric treatment

8. Use of anti-epilepsy drug, lithium, ethyl icosapentate and anti-coagulant drug (for
example, aspirin, warfarin, etc) within 3 month at regular intervals

9. Use of polyunsaturated fatty acid supplement within 3 month at regular intervals

10. Habit of eating fish over 4 times per week

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Total score of Clinician-Administrated PTSD Scale (CAPS)

Outcome Time Frame:

Three month

Safety Issue:


Principal Investigator

Yutaka Mastuoka, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Disaster Medical Center, Tachikawa, Tokyo ,Japan


Japan: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

February 2009

Related Keywords:

  • Trauma
  • Posttraumatic Stress Disorder
  • Patients
  • high-energy
  • admitted
  • intensive care unit
  • motor vehicle accident
  • falling from height
  • other accident
  • Stress Disorders, Post-Traumatic
  • Stress Disorders, Traumatic