A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
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 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 an 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 their 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
干预措施: ALKS 5461 (Drug)
Low Dose
干预措施: ALKS 5461 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
时间窗: Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect
The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
时间窗: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
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.
Change From Baseline to End of Treatment in the MADRS-10
时间窗: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
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)(5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2))
- Proportion of Patients Who Exhibited Treatment Response (MADRS-10)(5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2))
- Remission Rate(5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2))