An Open-label Study of ALTO-100 in Adults With Major Depressive Disorder and/or Post-traumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 22
- 主要终点
- To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinical Global Impression scale - Severity (CGI-S)
研究概览
简要总结
The goal 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 69 Years（Adult, Older 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 (MDD) and/or post-traumatic stress disorder (PTSD)
- •At baseline, either not taking an antidepressant medication, or currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
- •Willing to comply with all study assessments and procedures
- •Must not be pregnant or breastfeeding at time of enrollment or throughout study
排除标准
- •Evidence of unstable cardiovascular, respiratory, liver, or renal impairment or disease
- •Active suicidal ideation
- •Diagnosed bipolar disorder, psychotic disorder, or dementia
- •Current moderate or severe substance use 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 PO tablet, 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 clinical outcome with ALTO-100 using the Clinical Global Impression scale - Severity (CGI-S)
时间窗: Measured 5 times over 8 weeks
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 change from baseline to the end of the study is the primary outcome.
Number of Participants With Clinically Significant Vital Signs 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 11 weeks)
Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: Measured 5 times over 8 weeks
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 change from baseline to the end of the study is the primary outcome.
To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Measured 3 times over 8 weeks
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. The change from baseline to the end of the study 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 12 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 11 weeks)
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.
次要结局
未报告次要终点