A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ALKS 33-BUP Administration in Subjects With Major Depressive Disorder (MDD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The number and percent of subjects with treatment-emergent adverse events following sublingual administration of ALKS 33 and buprenorphine co-formulation (ALKS 5461)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are inadequately/partially responding to current treatment with a stable dose of a serotonin-selective reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between 18 and 65 years of age, inclusive.
- •Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD.
- •Current episode lasting ≥8 weeks prior to screening with an inadequate/partial response to an adequate trial (defined as at least 8 weeks) of a stable dose of an SSRI or SNRI. Inadequate/partial response is defined as:
- •A Hamilton Depression Rating Scale total score (HAM-D17) ≥14, and
- •Less than 50% reduction in depressive symptom severity on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ), and
- •Clinical Global Impression - Severity (CGI-S) score of ≥3.
排除标准
- •Axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder, obsessive-compulsive disorder, panic disorder, or posttraumatic stress disorder.
- •A clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.
- •Experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode.
- •The use of inducers or inhibitors of cytochrome P450 (CYP) 3A4 (prescription medications, over-the-counter [OTC] medications, or dietary supplements) within 30 days before dosing.
- •Have received electroconvulsive therapy during the current MDD episode.
- •Pose current suicide risk as confirmed by the Columbia Suicide Severity Rating Scale (C SSRS).
- •History of intolerance or hypersensitivity to buprenorphine.
- •History of allergy or hypersensitivity to opioid antagonists (eg, naltrexone, naloxone) or quinine.
研究组 & 干预措施
ALKS 5461 (ALKS 33 and buprenorphine)
干预措施: ALKS 5461 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The number and percent of subjects with treatment-emergent adverse events following sublingual administration of ALKS 33 and buprenorphine co-formulation (ALKS 5461)
时间窗: 7 days
Measured over a range of dose levels in subjects with inadequate/partial response to antidepressant therapy during the current episode of MDD.
次要结局
未报告次要终点