A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 81
- 主要终点
- Time to relapse
研究概览
简要总结
The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.
详细描述
GAD is a common and disabling mental disorder associated with substantial medical and psychiatric comorbidity and occupational impairment. It is characterized by inappropriate or excessive anxiety and worrying that persists over time for more than six months. Common features include apprehension, with worries about future misfortune; inner tension and difficulty in concentrating; motor tension, with restlessness, tremor and headache; and autonomic anxiety symptoms, with excessive perspiration, dry mouth and epigastric discomfort. GAD is typically a chronic disorder with a high relapse rate and therefore requires effective long-term treatment. Long-term studies are necessary to demonstrate that the short-term effect is maintained.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has GAD as the primary diagnosis according to DSM-IV-TR criteria (classification code 300.02).
- •The patient has a HAM-A total score >=20 at screening and baseline visits
- •The patient has a HAM-A score >=2 on both Item 1 (anxious mood) and Item 2 (tension) at screening and baseline visits
- •The patient has a MADRS total score <=16 at screening and baseline visits
排除标准
- •Any current psychiatric disorder other than GAD as defined in the DSM-IV-TR (assessed with the MINI)
- •Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
- •Women of childbearing potential not using effective contraception
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Lu AA21004
干预措施: Lu AA21004 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to relapse
时间窗: At least 24 weeks
次要结局
- Relapse rates, Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression Scale (CGI), MOS SF-36, Sheehan Disability Scale (SDS), Adverse events, Clinical laboratory tests, Vital signs, ECG(At least 24 weeks)