CompletedPhase 3

Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study

Japan110 participantsStarted 2008-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 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

What they're measuring

Total score of Clinician-Administrated PTSD Scale

Timeframe: Three month

Trial details

NCT IDNCT00671099

SponsorJapan Science and Technology Agency

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08

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