Omega-3 Fatty Acids and PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Clinician-Administered PTSD Scale (CAPS)
研究概览
简要总结
An increasing literature shows that omega-3 fatty acids provide numerous health benefits, including a variety of psychiatric symptoms and disorders including stress, anxiety, cognitive impairment, mood disorders (major depression and bipolar disorder) and schizophrenia. Omega-3 fatty acids may additionally represent a promising treatment strategy in patients with PTSD. Moreover, given its beneficial cardiovascular effects, adjunctive omega-3 fatty acids may also benefit the general health status of these veterans, who frequently present with a variety of comorbid medical disorders.
详细描述
See brief summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans 18-65 years of age, any ethnic group, either sex.
- •Ability to participate fully in the informed consent process.
- •Current diagnosis of PTSD .
- •No anticipated need to alter medications for the 10-week duration of the study.
排除标准
- •Serious unstable medical illness, history of traumatic brain injury (TBI) with loss of consciousness greater than 30 minutes, or history of cerebrovascular accident, prostate or breast cancer.
- •Current active suicidal and/or homicidal ideation, intent or plan.
- •Use of aspirin, warfarin or other anticoagulant therapy, as omega-3 fatty acids may increase bleeding time. Other concomitant medications for medical conditions will be addressed on a case-by-case base and determined if exclusionary.
- •Regular use of omega-3 fatty acid supplementation within the last 3 months (cod liver oil, other fish oil, flaxseed).
- •Regular consumption of more than one serving of fatty fish per week.
- •Substance dependence within the last 4 weeks (other than nicotine dependence).
- •Current Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI.
- •Female patients who are pregnant or breast-feeding.
- •Known allergy to study medication.
研究组 & 干预措施
1
Omega-3 Fatty Acid
干预措施: Omega-3 Fatty Acid (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Clinician-Administered PTSD Scale (CAPS)
时间窗: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Mean change scores in posttraumatic stress disorder symptoms (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
Brief Assessment of Cognition in Affective Disorders (BAC-A)
时间窗: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Mean change scores to assess cognitive changes (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The BAC-A includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 10 (Week 2 minus Week 10).
次要结局
- Quick Inventory of Depressive Symptomatology (QIDS)(Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization))
- Connor Davidson Resilience Scale (CD-RISC)(Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization))
- Continuous Performance Test (CPT)(Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization))
- Trail Making A(Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization))
- Trail Making B(Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization))