A Randomized, Active-Controlled, Evaluation of AXS-05 for the Treatment of Treatment Resistant Depression in Treatment-Adherent Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score
研究概览
简要总结
The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug. Subjects are considered to have treatment-resistant MDD if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments (ADTs) and a prospective inadequate response to treatment with bupropion SR, during the current major depressive episode.
The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan (in the AXS-05 group) and bupropion (in the bupropion group), and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent. Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301.
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
- Double (Participant, Investigator)
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
- •Provided written informed consent to participate in Study AXS-05-301
- •Has treatment-resistant depression, defined as an inadequate response to 2 or 3 prior ADTs
- •Body mass index (BMI) between 18 and 40 kg/m2, inclusive
排除标准
- •Suicide risk
- •Treatment with any investigational drug within 6 months
- •History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months
- •Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
研究组 & 干预措施
AXS-05
45 mg dextromethorphan-105 mg bupropion
干预措施: AXS-05 (Drug)
Bupropion SR
150 mg bupropion
干预措施: Bupropion SR (Drug)
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
时间窗: Change from Baseline to Week 6
The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
次要结局
未报告次要终点