NCT02141399已完成3 期
A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,485
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to use an approved method of contraception for the duration of the study
- •Have the potential to safely benefit from the administration of ALKS 5461
- •Have a diagnosis of major depressive disorder (MDD)
- •Additional criteria may apply
排除标准
- •Have a positive test for drugs of abuse
- •Currently pregnant or breastfeeding
- •Have a current primary Axis-I disorder other than MDD
- •Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
- •Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime
- •Have attempted suicide within the past 2 years
- •Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
- •Have had a significant blood loss or blood donation within the past 60 days
- •Additional criteria may apply
研究组 & 干预措施
ALKS 5461
Experimental
干预措施: ALKS 5461 (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Up to 56 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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