A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of PRX-00023 in Patients With Major Depressive Disorder.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 19
- 主要终点
- Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
研究概览
简要总结
The purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of PRX-00023 in patients with major depressive disorder.
详细描述
Patients with major depressive disorder who meet all of the eligibility criteria will be randomly assigned to receive twice daily doses of either placebo or PRX-00023. Study drug will be taken for up to approximately 9 weeks. Patients will have periodic office visits for the purpose of monitoring safety and tolerability, as well as efficacy assessments.
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
- •Diagnosis of major depressive disorder
排除标准
- •Females who are pregnant or nursing
- •Electroconvulsive therapy within previous year
- •Type 1 diabetes or uncontrolled type 2 diabetes
- •HIV, Hepatitis B or Hepatitis C
- •Use of illegal drugs, history of drug abuse, and/or alcohol dependence
- •Clinically significant abnormal lab results
- •Other protocol-defined eligibility criteria may apply.
研究组 & 干预措施
1
PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg
干预措施: PRX-00023 (Drug)
2
Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg
干预措施: Placebo for PRX-00023 (Drug)
结局指标
主要结局
Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
时间窗: change from baseline through end of study
次要结局
- Side effects during and immediately following the treatment period(assessed throughout study)
- changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale(change from baseline through end of study)
- changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR)(change from baseline through end of study)
- changes from baseline on the Clinical Global Impressions (CGI) scale(change from baseline through end of study)
- responder and remission rates(change from baseline through end of study)
- changes from baseline on the Changes in Sexual Function (CSFQ) scale.(change from baseline through end of study)