A Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of ACP-211 Monotherapy in Adults With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 30
- 主要终点
- Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28
研究概览
简要总结
The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).
The main questions the study aims to answer are:
- Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression?
- What adverse events do participants have when taking ACP-211?
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
- •Adults ≥18 and ≤65 years of age
- •Provides written informed consent
- •Clinical diagnosis of MDD
- •History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode
- •Currently treated with an approved antidepressant at a stable dose prior to Screening
- •MADRS total score ≥28, CGI-S score ≥4 , and QIDS-SR16 score ≥16 at Screening and Baseline
- •Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation
排除标准
- •Current diagnosis of certain personality disorders or persistent depressive disorder
- •Recent substance use disorders, excluding caffeine or nicotine
- •Active suicidal risk or recent suicidal attempt
- •History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features
- •Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD
- •History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy)
- •Allergy or sensitivity to ketamine or esketamine
- •Significant cardiovascular disease
- •Positive history of hepatitis B, hepatitis C, or HIV infection
- •Unstable diabetes or uncontrolled medical conditions
- •Positive urine drug test for an illicit drug or cannabis
- •Received neuromodulation therapies (ECT, TMS, VNS, DBS) in the current depressive episode
- •Recent initiation or change in psychotherapy
- •Additional inclusion/exclusion criteria apply. Participants will be evaluated at Screening to ensure that all criteria for study participation are met.
研究组 & 干预措施
Placebo
Matching placebo, administered orally twice weekly
干预措施: Placebo (Drug)
ACP-211 600 mg
ACP-211 600 mg, administered orally twice weekly
干预措施: ACP-211 (Drug)
ACP-211 300 mg
ACP-211 300 mg, administered orally twice weekly
干预措施: ACP-211 (Drug)
结局指标
主要结局
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28
时间窗: Baseline and Day 28
The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity.
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 28
时间窗: Baseline and Day 28
The MADRS is a clinician-rated tool that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity.
次要结局
- Proportion of Subjects With Response at Scheduled Postbaseline Visits (≥50% Reduction From Baseline in MADRS Total Score)(Up to Day 28)
- Proportion of Subjects in Remission at Scheduled Postbaseline Visits (MADRS ≤10)(Up to Day 28)
- Change From Baseline in MADRS Total Score at Day 2(Baseline and Day 2 (24 hours postdose))
- Change From Baseline in MADRS Total Score at Scheduled Postbaseline Visits(Baseline through Day 28)
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Scheduled Postbaseline Visits(Baseline through Day 28)
- Proportion of Subjects With Sustained Response From Day 2 Through Day 28(Day 2 through Day 28)
- Proportion of Subjects With Clinical Global Impression of Improvement (CGI-I) Score of 1 or 2 at Scheduled Postbaseline Visits(Up to Day 28)
- Change from Baseline in the MADRS total score postdose at 24 hours (Day 2)(Baseline and Day 2)