A Randomized, Double-blind, Placebo-controlled Trial of ALTO-207 in Adults With Treatment-resistant Depression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 48
- 主要终点
- Change in the MADRS total score
研究概览
简要总结
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
- •Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
- •Failure to respond (<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
- •Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline
排除标准
- •Evidence of unstable medical condition
- •Concurrent use of any prohibited medications or substance use disorder
- •Diagnosed bipolar disorder or a psychotic disorder or symptoms
- •Significant current PTSD symptoms or history of PTSD
- •Clinically significant current impulse control difficulties
- •Has a history of hypersensitivity or allergic reaction to ALTO-207 or any of its components/excipients
- •Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
研究组 & 干预措施
ALTO-207
干预措施: ALTO-207 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the MADRS total score
时间窗: Change from baseline up to 8 weeks
Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
次要结局
- Change in response (≥50% improvement) raters based on MADRS(Change from baseline up to 8 weeks)
- Change in the Clinician-administered CGI-S score over time from Baseline to Week 8(Change from baseline up to 8 weeks)