NCT00612859已完成2 期
A Multicenter, Randomized, Double-Blind, PBO-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Levetiracetam Versus PBO for the Treatment of Social Anxiety Disorder (Generalized Type)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 217
- 主要终点
- change in Liebowitz Social Anxiety Scale (LSAS) score from Visit 2 to the last Evaluation period visit attended using last observation carried forward (LOCF) methods
研究概览
简要总结
Preclinical and clinical findings indicate that LEV has some anxiolytic potential. There is reason to believe that compounds with anxiolytic activity may have broad clinical utility across the anxiety spectrum. This trial was intended to explore LEV's utility in adults with social anxiety disorder.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients between 18 and 70 years old inclusive;
- •symptoms of social anxiety disorders (generalized type) present for at least 1 year prior to Selection Visit;
- •had a score of >=60 on the LSAS at the Selection Visit and at the Randomization Visit. Additionally, the clinician's gloal impression of change score must have been >= 2 at the Randomization Visit;
- •had a telephone where they could be directly contacted.
排除标准
- •History of autism or Asperger's Disease;
- •had another primary axis I disorder or fulfilled diagnostic and statistical manual of mental disorders-4th edition (DSM-IV) criteria in the 6 months prior to Screening;
- •major depression as measured by a Hamilton Depression Rating Scale (HAM-D-17 items) total score of > 17 and/or a suicide subscale score on the HAM-D-17 items of > 2 at the Selection or Randomization Visit;
- •history of electroconvulsive therapy within the prior 3 months;
- •history of psychotherapy which was not stable and ongoing for at least 6 months prior to Visit 1;
- •clinical history of significantly impaired renal function with an estimated creatinine clearance below 80 mL/min;
- •clinically significant medical condition;
- •history of any clinically significant allergic condition or allergy to LEV or pyrrolidone derivatives;
- •neutrophil count of less than 1800/µL.
结局指标
主要结局
change in Liebowitz Social Anxiety Scale (LSAS) score from Visit 2 to the last Evaluation period visit attended using last observation carried forward (LOCF) methods
Safety: monitoring of AEs, clinical laboratory tests, physical examination and vital signs.
次要结局
未报告次要终点
研究者
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