NCT02158546已完成3 期
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-3 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
- 447
- 试验地点
- 2
- 主要终点
- Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
This study will evaluate the efficacy and safety of ALKS 5461.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
- •Agree to use an acceptable method of contraception for the duration of the study
- •Have a Major Depressive Disorder (MDD) primary diagnosis
- •Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
- •Additional criteria may apply
排除标准
- •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 one course of electroconvulsive treatment during lifetime
- •Have attempted suicide within the past 2 years
- •Have a positive test for drugs of abuse
- •Are pregnant, planning to become pregnant, or breastfeeding
- •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 60 days
- •Additional criteria may apply
研究组 & 干预措施
ALKS 5461
Experimental
干预措施: ALKS 5461 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline and week 6
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
次要结局
- Number of Subjects With Adverse Events (AEs)(6 weeks)
- Proportion of Patients Who Exhibited Treatment Response (MADRS-10)(6 weeks)
- Remission Rate(6 weeks)
研究者
研究点 (2)
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