An Eight-week, Multicenter, Double-blind, Placebo- and Paroxetine-controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Generalized Anxiety Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.
研究概览
简要总结
The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with generalized 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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of generalized anxiety disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI) General Anxiety Disorder (GAD) Plus Module.
排除标准
- •Total score of less than 22 on the (Hamilton Anxiety rating scale)HAM-A.
- •Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than
- •Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.
- •Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
- •Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine oxidase inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.
- •The investigator will evaluate whether there are other reasons why a patient may not participate.
研究组 & 干预措施
SSR149415 - 100 mg
SSR149415 100 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks
干预措施: Placebo (Drug)
SSR149415 - 250 mg
SSR149415 250 mg, twice daily for a maximum of 8 weeks
干预措施: SSR149415 (Drug)
SSR149415 - 100 mg
SSR149415 100 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks
干预措施: SSR149415 (Drug)
Paroxetine
Paroxetine 20 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks
干预措施: Placebo (Drug)
Paroxetine
Paroxetine 20 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks
干预措施: Paroxetine (Drug)
Placebo
Placebo for a maximum of 9 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.
时间窗: 8 weeks
次要结局
- Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.(8 weeks)