Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety scale (HAM-A)
研究概览
简要总结
The main purpose of this research study is to determine whether the drug Levetiracetam (Keppra™) is effective in the prevention of panic attacks. The drug Levetiracetam (Keppra™) has been approved for the treatment of seizures by the U.S. Federal Food and Drug Administration (FDA) and is available by prescription. Levetiracetam has not been approved by the FDA for the treatment of panic disorder.
详细描述
a) Methods and Procedures:
Study Treatment:
Study drug and dosing: Levetiracetam open-label, with the following titration schedule to begin after the initial lactate infusion:
Study day Levetiracetam dose 1-4 250 mg 5-7 500 mg 8-10 750 mg 11-14 1000 mg 15-18 1500 mg 19-21 2000 mg 22-25 2500 mg 26-28 3000 mg 29-56 3000 mg
Levetiracetam will be titrated to maximized clinical response (total reduction of panic attacks and intervening anxiety) and minimize side effects. Subjects who develop bothersome side effects will be permitted to have a dose reduction to alleviate such side effects. Subjects unable to tolerate levetiracetam 500 mg/d will be discontinued from the trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Outpatient subjects age 18 years or older.
- •Subjects must meet DSM-IV-TR criteria for panic disorder with or without agoraphobia.
- •Subjects must experience a minimum of one panic attack per week over the month preceding the study.
- •Subjects must be fluent in English.
- •Subjects must be able to provide and understand written informed consent.
排除标准
- •Subjects unable to provide and understand written informed consent.
- •Subjects previously treated with levetiracetam.
- •Subjects who meet DVM-IV-TR criteria for current diagnosis of mood, psychotic or substance use disorder.
- •Subjects who have acute or unstable medical illness.
- •Subjects with a history of seizures or structural brain damage from trauma.
- •Subjects currently receiving successful treatment for panic disorder (i.e., subjects will not have medications discontinued to participate in the study if they are effective in the treatment of their panic attacks).
- •Subjects susceptible to lactate infusions.
- •Female subjects who are pregnant or lactating.
- •Female subjects who, if fertile, are not using medically acceptable and reliable method of contraception.
研究组 & 干预措施
Levetricetam
open label treatment
干预措施: levetiracetam (Drug)
结局指标
主要结局
Hamilton Anxiety scale (HAM-A)
时间窗: each visit
次要结局
未报告次要终点