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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Trauma, Posttraumatic Stress Disorder

Intervention / Treatment
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* Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score of Clinician-Administrated PTSD Scale (CAPS) |  | Three month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of diagnosis of PTSD (including partial PTSD) |  | Three month, one month | 
| Total score of Montgomery Asberg Depression Rating Scale (MADRAS) |  | Three month, one month | 
| Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI) |  | Three month, one month | 
| Autonomic response measured before, during and after script driven imagery and acoustic stimulation |  | Three month | 
| Score of Impact of Event Scale revised (IES-R) |  | Three month, one month | 
| Score of Hospital Anxiety and Depression scale (HADS) |  | Three month, one month | 
| Score of health related Quality of Life scale, SF-36 |  | Three month, one month | 
| Score of Conner-Davidson Resilience Scale (CD-RISC) |  | Three month, one month | 
| Brain-derived neurotrophic factor (BDNF) in serum |  | Three month, one month | 
| Number of days of leave taken from the time of injury |  | Three month | 
| Buss-Perry Aggression Questionnaire (BAQ) |  | Three month, one month, baseline | 
| Total score of Clinician-Administrated PTSD Scale (CAPS) |  | One month | 
| DHEA: dehydroepiandrosterone |  | Three month, one month | 
| NPY: neuropeptide Y |  | Three month, one month | 
| IL-1 beta: interleukin 1 beta |  | Three month, one month | 
| IL-6: interleukin 6 |  | Three month, one month | 
| TNF alpha: tumor necrosis factor alpha |  | Three month, one month | 
| D-serine |  | Three month, one month | 
| L-serine |  | Three month, one month | 
| DL-serine |  | Three month, one month | 
| Activin |  | Three month, one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients, high-energy, admitted, intensive care unit, motor vehicle accident, falling from height, other accident