A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Clinical Global Impressions - Improvement (CGI-I)
研究概览
简要总结
The purpose of this study is to evaluate the short-term efficacy and safety of levetiracetam in post-traumatic stress disorder (PTSD) and to evaluate continuation effects of levetiracetam in preventing PTSD relapse. The hypothesis is that levetiracetam will be safe and effective in preventing relapse of PTSD.
详细描述
This is an investigator-initiated, single site study, consisting of two phases: 8 weeks of open label treatment with levetiracetam (500-2000 mg/day) in patients with PTSD, and in those who demonstrate at least minimal improvement, 12 weeks of randomized, double-blind treatment with either levetiracetam or matching placebo.
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 (Participant, Investigator)
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
- •ages 18-65
- •primary diagnosis of PTSD based on DSM-IV criteria and assessed by the MINI International Neuropsychiatric Interview (MINI)
- •Davidson Trauma Scale (DTS) score of at least 40 on screening
- •ability to provide written informed consent
排除标准
- •any primary DSM-IV Axis I disorder other than PTSD
- •substance abuse during the last 6 months
- •a clinically unstable medical condition or clinically significant laboratory abnormalities
- •suicide risk or serious suicide attempt during the last year
- •concurrent use of psychotropic medications including benzodiazepines, barbiturates, antiepileptic drugs, antidepressants, buspirone, dietary supplements or herbal or homeopathic remedies with psychotropic effects
- •recent (within the last 3 months) initiation of cognitive behavioral therapy
- •failure of a previous trial of levetiracetam at 2000 mg/day
- •pregnancy or lactation
- •women of childbearing potential who are unwilling to practice an acceptable method of contraception
研究组 & 干预措施
1
Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial.
干预措施: Placebo (Drug)
2
Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.
干预措施: levetiracetam (Drug)
2
Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.
干预措施: Levetriracetam (Drug)
结局指标
主要结局
Clinical Global Impressions - Improvement (CGI-I)
时间窗: 20 wks
次要结局
- Sheehan Disability Inventory (SDI)(20 wks)
- Davidson Trauma Scale (DTS)(20 wks)
- Hospital Anxiety and Depression Scale (HADS)(20 wks)
- Connor-Davidson Resilience Scale (CD-RISC)(20 wks)
- 36-item Short Form Health Survey (SF-36)(20 wks)
- Pittsburgh Sleep Quality Index(20 wks)
- Work Productivity and Activity Improvement Questionnaire (WPAI)(20 wks)