A Randomized Placebo-Controlled Trial of Sertraline for the Neurobehavioral Sequelae of Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Montgomery Asberg Depression Rating
研究概览
简要总结
The purpose of this study is to investigate the efficacy of an SSRI, sertraline for the use of post-concussive symptoms following a traumatic brain injury. the study also seeks to investigate the relationship between irritability and aggression and anosmia in individuals who have suffered a traumatic brian injury.
详细描述
The objectives of this protocol are the following:
- To investigate the efficacy of sertraline, a selective serotonin reuptake inhibitor (SSRI), in treating neurobehavioral sequelae of irritability, depression, frustration, anxiety and other post-concussive symptoms following traumatic brain injury (TBI).
- To explore possible relationships between anosmia (deficits in smell) and irritability/ aggression.
This study will test the hypotheses:
Sertraline is effective in treating Post TBI neurobehavioral symptoms of irritability, depression, frustration, anxiety, and other elements of the postconcussive syndrome.
Patients who receive sertraline will have significantly less post-concussive symptoms at 12 weeks than patients who received placebo. Post-concussive symptoms will be measured by the Gouvier Post-Concussive Syndrome Scale (PCSC) and the Affective Cluster score of the Cicerone Post Concussive Scale.
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
- Double
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
- 是
入选标准
- •Traumatic brain injury patients within 6 months of injury.
- •Traumatic brain injury with:
- •Minimum severity - TBI with post traumatic amnesia.
- •Maximum severity - recovery to a Rancho los Amigos (see Appendix II) level 7 or 8 by six months after injury.
- •The C Criterion of DSM IV diagnosis of Post Concussive Disorder (PCD- Research Criteria), with symptoms persisting for a minimum of 4 weeks.
- •Military beneficiary.
排除标准
- •Severe prior neurologic or psychiatric illness, such as stroke or psychosis. (Previous nonpsychotic depression is not an exclusion criterion)
- •Contraindication to the use of sertraline.
- •Previous severe traumatic brain injury (defined as TBI with period of unconsciousness greater than 1 week prior. This exclusion refers only to TBI's prior to the current injury, which is within the past 6 months).
- •Pregnancy
- •Current active suicidal ideation
结局指标
主要结局
Montgomery Asberg Depression Rating
Diagnosis of PCD by DSM-IV
Gouvier-PCSC
Post Concussive Scale
Hamilton Depression Scale
次要结局
- Smell Identification Test