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| Name | Class |
|---|---|
| University of Toyama | OTHER |
| Chiba University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Polyunsaturated Fatty Acid | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total score of Clinician-Administrated PTSD Scale | Three month |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yutaka Matsuoka, M.D.,Ph.D. | National Disaster Medical Center, Tachikawa, Tokyo ,Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Disaster Medical Center | Tachikawa | Tokyo | 1900014 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23289548 | Background | Matsuoka Y, Nishi D, Yonemoto N, Hamazaki K, Matsumura K, Noguchi H, Hashimoto K, Hamazaki T. Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial. BMC Psychiatry. 2013 Jan 5;13:8. doi: 10.1186/1471-244X-13-8. | |
| 38767196 | Derived |
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| Placebo | Dietary Supplement | Placebo |
|
| 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 |
| Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2. |
| 35141873 | Derived | Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2. |
| 26335087 | Derived | Matsuoka Y, Nishi D, Hamazaki K, Yonemoto N, Matsumura K, Noguchi H, Hashimoto K, Hamazaki T. Docosahexaenoic acid for selective prevention of posttraumatic stress disorder among severely injured patients: a randomized, placebo-controlled trial. J Clin Psychiatry. 2015 Aug;76(8):e1015-22. doi: 10.4088/JCP.14m09260. |
| 26151924 | Derived | Matsuoka Y, Nishi D, Tanima Y, Itakura M, Kojima M, Hamazaki K, Noguchi H, Hamazaki T. Serum pro-BDNF/BDNF as a treatment biomarker for response to docosahexaenoic acid in traumatized people vulnerable to developing psychological distress: a randomized controlled trial. Transl Psychiatry. 2015 Jul 7;5(7):e596. doi: 10.1038/tp.2015.89. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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