NCT00191022已完成2 期
A Randomized, Double-Blind Comparison of LY686017, Paroxetine, and Placebo in the Treatment of Social Anxiety Disorder
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 16
- 主要终点
- Superiority is defined as a statistically greater reduction of the mean change from baseline to endpoint (after 12 weeks of treatment) in the Liebowitz Social Anxiety Scale (LSAS) total score.
研究概览
简要总结
This study is a Phase 2 trial to test the efficacy of LY686017 in the treatment of 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients at least 18 years of age and not more than 65 years of age.
- •Must sign the informed consent document.
- •Present at Visit 1 with social anxiety disorder based on a Clinical Global Impression-Severity score of greater than or equal to
- •Females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use both a reliable primary method of birth control.
- •Judged to be reliable and willing to keep all appointments for clinic visits, tests, and procedures required by the protocol.
排除标准
- •Have any comorbid Axis I disorders (such as major depression, obsessive compulsive disorder, post-traumatic stress disorder, or panic disorder), in the opinion of the investigator, if the disorder occurred within the last 6 months.
- •Have had any previous or current diagnoses of bipolar disorders, schizophrenia, or other psychotic disorders.
- •Have the presence of an Axis II disorder, except avoidant personality disorder.
- •Have a serious medical illness.
- •Have abnormal thyroid-stimulating hormone (TSH) concentrations or are taking thyroid supplements.
结局指标
主要结局
Superiority is defined as a statistically greater reduction of the mean change from baseline to endpoint (after 12 weeks of treatment) in the Liebowitz Social Anxiety Scale (LSAS) total score.
次要结局
- To compare the safety and tolerability of LY686017 with placebo during 12-week treatment.
- To evaluate efficacy of LY686017 compared with placebo in treatment of social anxiety disorder during 12-week therapy based on mean improvement in the following measures:
- The Liebowitz Social Anxiety subscale scores
- The Clinical Global Impression-Improvement scale
- The Hamilton Anxiety Scale total score and
- The Clinical Global Impression-Severity scale
- To assess the efficacy of LY686017 compared with placebo on health outcomes as measured by the Sheehan Disability scale.
- To investigate the population pharmacokinetics of LY686017 following multiple administrations of LY686017.
- To ascertain whether another approved marketed drug for
- social anxiety disorder is statistically significantly more efficacious than placebo in this study.
研究者
研究点 (16)
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