An Open-Label Study of ALTO-100 in Adults With Major Depressive Disorder (MDD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- To understand the relationship between baseline biology and score change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-100 from start of dosing to end of treatment
研究概览
简要总结
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-100.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of moderate to severe major depressive disorder
- •Either currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication
- •Willing to comply with all study assessments and procedures
- •Must not be pregnant or breastfeeding at time of enrollment or throughout study
- •Must have access with privacy to a computer with a keyboard and internet
排除标准
- •Evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease
- •Active suicidal ideation
- •Severe impediment to vision, hearing, and/or hand movement
- •Diagnosed bipolar disorder or psychotic disorder
- •Has a history of hypersensitivity or allergic reaction to ALTO-100 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-100
ALTO-100 tablet PO ; twice daily dosing 8 weeks
干预措施: ALTO-100 PO Tablet (Drug)
结局指标
主要结局
To understand the relationship between baseline biology and score change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-100 from start of dosing to end of treatment
时间窗: Measured at Day 1, Day 14, Day 28, Day 42, Day 56
The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. The score change from the start of dosing (Day 1) to the end of treatment (Day 56) is the primary outcome.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100
时间窗: From the signing of the ICF until the follow-up visit (up to 13 weeks)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100
时间窗: From the signing of the ICF until the end-of-treatment visit (up to 13 weeks)
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.
To understand the relationship between baseline biology and score change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-100 from Screening to end of treatment
时间窗: Measured at Screening, Day 1, Day 14, Day 28, Day 42, Day 56
The Clinical Global Impression scale - Severity (CGI-S) measures the severity of psychopathology in general where smaller scores indicate less illness and higher scores suggest more severe illness. Possible scores for this scale range from 1 to 7. The score change from Screening (Day \[-21\]) to the end of treatment (Day 56) is the primary outcome.
次要结局
未报告次要终点