Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Total score of Clinician-Administrated PTSD Scale
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Total score of Clinician-Administrated PTSD Scale
时间窗: Three month
次要结局
- D-serine(Three month, one month)
- L-serine(Three month, one month)
- DL-serine(Three month, one month)
- Activin(Three month, one month)
- Incidence of diagnosis of PTSD (including partial PTSD)(Three month, one month)
- Brain-derived neurotrophic factor (BDNF) in serum(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)
- NPY: neuropeptide Y(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)
- 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)
研究者
Yutaka Matsuoka
Psychiatrist
Japan Science and Technology Agency