Adjunctive Pregnenolone in Veterans With Mild TBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Brief Assessment of Cognition in Affective Disorders (BAC-A)
研究概览
简要总结
Mild traumatic brain injury (TBI) is common among veterans who have served in OEF/OIF (Operation Enduring Freedom in Afghanistan/Operation Iraqi Freedom) and other theatres. Delayed symptoms may occur following TBI, including cognitive symptoms (impaired attention, processing speed, executive functioning), as well as behavioral symptoms such as anxiety, depression, and irritability (Fann et al. 2004; Holsinger et al. 2002). Neuroactive steroids have neuroprotective effects in rodent models of TBI (Djebaili et al. 2005; Djebaili et al. 2004; He et al. 2004; Pettus et al. 2005; Roof et al. 1997) and the neuroactive steroid pregnenolone and its sulfated derivative also markedly enhance learning and memory in rats (Akwa et al. 2001; Flood et al. 1992; Flood et al. 1995; Vallee et al. 1997; Vallee et al. 2003). In humans, reductions in pregnenolone (George et al. 1994) and its GABAergic metabolite allopregnanolone (Uzunova et al. 1998) have been associated with depressive symptoms. Pharmacological intervention with the neuroactive steroid pregnenolone could therefore result in a multi-targeted treatment approach, potentially improving cognitive deficits as well as anxiety and depression symptoms following TBI.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-55 years of age, any ethnic group, either sex
- •History of mild TBI since September
- •TBI occurring at age 18 or older.
- •We will adhere to the operational definition of mild TBI suggested by the World Health Organization Task Force (Holm et al.2005), with the exception of the Glasgow Coma Scale Score criteria (not available for these participants).
- •Ability to participate fully in the informed consent process.
- •No anticipated need to alter medications for the 10-week duration of the study.
排除标准
- •For this pilot study, we will exclude patients who report a history of seizures.
- •Serious unstable medical illness. History of cerebrovascular accident, prostate, uterine, or breast cancer. Use of oral contraceptives or other hormonal supplementation such as estrogen.
- •Current active suicidal and/or homicidal ideation, intent or plan.
- •Concomitant medications for medical conditions will be addressed on a case-by-case base and determined if exclusionary.
- •Current DSM-IV (Diagnostic and Statistical Manual, Fourth Edition) 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
Pregnenolone
干预措施: Pregnenolone (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Brief Assessment of Cognition in Affective Disorders (BAC-A)
时间窗: Week 2, Week 10
Mean change scores (Week 2 minus Week 10) to assess cognitive changes. 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
- Clinician Administered PTSD Scale (CAPS)(Week 2, Week 10)
- Quick Inventory of Depressive Symptomatology (QIDS)(Week 2, Week 10)