NCT00322803终止2 期
International, Multicenter, Randomized, Double-Blind, Placebo Controlled, Two-Period, Cross-Over Study to Demonstrate Safety, Tolerability and Anxiolytic Effects of 600 mg ELB139 Given Orally t.i.d. to Patients With Concurrent Panic Disorder, Challenged by Inhalation of 35% CO2 After a Single Dose and One Week of Treatment
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- elbion AG
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)
研究概览
简要总结
This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Diagnosis of concurrent panic disorder
- •At least 2 panic attacks within the 4 weeks before the screening visit
- •Naïve to the CO2 challenge test
- •Age 18-65 years (inclusive)
- •Ability to comply with all procedures mandated by the study protocol
- •Negative pregnancy test and adequate contraceptive measures
排除标准
- •History of poly-pharmacotherapy for panic disorder or treatment resistance
- •Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia
- •History of abuse of benzodiazepines or tolerance to effects of benzodiazepine
- •Any concomitant psychotropic medication
- •Evidence of impaired hepatic, renal or cardiac functions
- •Participation in any drug trial in the preceding 6 months
结局指标
主要结局
degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)
difference of the degree of anxiety measured as the difference between the pre- and post challenge scores on the Visual Analogue Scale for Anxiety (VAS-A-delta)
次要结局
- Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta)
- Total Symptom Score assessed immediately after CO2 challenge (TSS-post)
研究者
研究点 (6)
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