A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores
研究概览
简要总结
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
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 Major Depressive Disorder (MDD) primary diagnosis
- •Have a body mass index (BMI) of 18.0 to </= 40.0 kg/m^2
- •Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)
- •Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
- •Additional criteria may apply
排除标准
- •Has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
- •Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
- •Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
- •Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
- •Has been hospitalized for MDD within 3 months before screening
- •Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening
- •Has received electroconvulsive therapy treatment within the last 2 years or within the current MDE or failed a course of electroconvulsive treatment at any time
- •Has a significant risk for suicide
- •Has a positive breath alcohol test at screening
- •Has a positive test for drugs of abuse at screening or visit 2
- •Is pregnant, planning to become pregnant, or is breastfeeding during the study
- •Additional criteria may apply
研究组 & 干预措施
ALKS 5461
Sublingual tablets
干预措施: ALKS 5461 (Drug)
ALKS 5461 Placebo
Sublingual tablets
干预措施: ALKS 5461 Placebo (Drug)
结局指标
主要结局
Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores
时间窗: Baseline and 5 weeks for Stage 1, Baseline 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 Major Depressive Disorder (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
- Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate(5 weeks for Stage 1, 6 weeks for Stage 2)
- Montgomery Asberg Depression Rating Scale (MADRS) Response Rate(Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2)