NCT03078322已完成2 期
Double-Blind, Placebo-Controlled, Phase 2 Trial to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) as Adjunct to Current Antidepressant Therapy in Patients With Major Depressive Disorder (the ELEVATE Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10)
研究概览
简要总结
The study will evaluate the safety and efficacy of AV-101.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with MDD, single or recurrent, and currently experiencing a MDE of at least 8 weeks in duration.
- •Has a history of inadequate response to at least 1 approved antidepressant including at least 1 and no more than 3 during the current depressive episode.
- •Meet the threshold on the total HAMD-17 score of > 20
- •If female, a status of nonchildbearing potential or use of an acceptable form of birth control.
- •Body mass index between 18 to 40 kg/m
- •Other criteria may apply
排除标准
- •History of bipolar disorder, schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
- •Any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within 6 months prior to screening.
- •Women who are pregnant or breastfeeding or a positive pregnancy test at screening or baseline.
- •Currently taking a prohibited adjunct therapy. Such drugs must be washed out for at least 4 weeks prior to baseline.
- •Current diagnosis of moderate or severe substance use (including alcohol) disorder (abuse or dependence, as defined by DSM-5), with the exception of nicotine dependence, at screening or within 6 months prior to screening.
- •In the opinion of the investigator, the subject has a significant risk for suicidal behavior
- •Has received electroconvulsive therapy, or had repetitive transcranial magnetic stimulation in the current episode.
- •Has received vagus nerve stimulation at any time prior to screening.
- •Any current or past history of any physical condition, which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
研究组 & 干预措施
AV-101
Experimental
L-4-chlorokynurenine 1440 mg daily for 14 days
干预措施: AV-101 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10)
时间窗: 2 weeks
Depression questionnaire
次要结局
- Time course of improvement including response rates(2 weeks)
- Safety and tolerability will be assessed by incidence of adverse events (AEs)(2 weeks)
研究者
研究点 (1)
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