NCT02158533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-4 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
- 385
- 试验地点
- 2
- 主要终点
- Change From Baseline to Week 5 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
High Dose
Experimental
干预措施: High Dose ALKS 5461 (Drug)
Low Dose
Experimental
干预措施: Low Dose ALKS 5461 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline and 5 weeks for each stage
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
- Proportion of Patients Who Exhibited Treatment Response (MADRS-10)(Baseline and 5 weeks for each stage)
- Remission Rate(Baseline and 5 weeks for each stage)
- Number of Subjects With Adverse Events (AEs)(5 weeks for Stage 1 and 6 weeks for Stage 2)
研究者
研究点 (2)
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