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

Japan Science and Technology Agency

Status and phase: Completed; Phase 3

Conditions: Posttraumatic Stress Disorder; Trauma

Treatments: Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00671099

NDMC-TPOP-02

Details and patient eligibility

About

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.

Full 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 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

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 plus years
2. A native Japanese speaking ability
3. Possibility to 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid

Treatment:

Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid

2

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo