NCT04832425已完成2 期
A Phase 2/3 Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Major Depressive Disorder
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of PRAX-114 in participants with moderate to severe major depressive disorder (MDD). Participants will be randomized to receive 28 days of either 40 mg PRAX-114 or placebo in a 1:1 ratio.
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
- •Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and no more than 24 months.
- •HAM-D17 total score of ≥23 at Screening and Baseline.
- •Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).
排除标准
- •Lifetime history of seizures, including febrile seizures.
- •Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease).
- •Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive compulsive disorder or a history of a psychotic mood episode in last 2 years.
- •Any current psychiatric disorder (other than MDD).
- •Lifetime history of treatment resistant depression.
- •Received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) within the last year or transcranial magnetic stimulation (TMS) within the last 6 months prior to Screening.
- •Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.
研究组 & 干预措施
PRAX-114
Experimental
40 mg PRAX-114 once daily
干预措施: PRAX-114 (Drug)
Placebo
Placebo Comparator
Placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15
时间窗: 15 days
The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
次要结局
- HAM-D17 remission (total score of ≤7) at Day 15, Day 29, and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
- Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior(Up to 43 days)
- Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
- Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
- Change from baseline in HAM-D17 total score at Day 29(29 days)
- Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
- Incidence of AEs by preferred term(Up to 43 days)
- Change from baseline in HAM-D17 total score at all other time points(8 days, 22 days, 36 days, and 43 days)
- HAM-D17 response (reduction from baseline score of ≥50%) at Day 15, Day 29, and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
- Change from baseline in the Symptoms of Depression Questionnaire (SDQ) total and sub-scale scores at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
- Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
- Change from baseline in the 12-Item Short Form Survey (SF-12) at Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 36 days, and 43 days)
- Incidence and severity of Adverse Events (AE)(43 days)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic MastocytosisNCT04910685Blueprint Medicines Corporation534
终止
2 期
ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19COVID-19NCT04393038Abivax S.A.509
Unknown
3 期
The Efficacy, Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19COVID-19NCT04659239Chinese Academy of Medical Sciences34,020
Unknown
2 期
To Evaluate SSD8432/Ritonavir in Adults With COVID-19COVID-19NCT05373433Jiangsu Simcere Pharmaceutical Co., Ltd.670
尚未招募
2 期
Efficacy and Safety of DT01 Tablets in Patients With Irritable Bowel Syndrome With DiarrheaIrritable Bowel Syndrome With DiarrheaNCT05719896Centre of Clinical Pharmacology, Hanoi Medical University120