A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NV-5138 in Adults With Treatment Resistant Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Evaluation of the efficacy of NV-5138 as measured by the Montgomery-Asberg Depression Rating scale
研究概览
简要总结
This study will evaluate the efficacy and safety of NV-5138 in adults with TRD
详细描述
The is a multicenter, randomized, double-blind, flexible- dose, placebo-controlled, parallel design of adjunctive NV-5138 in adults 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
matched placebo
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 70 years at Screening.
- •Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for either recurrent or single episode MDD without psychotic features that is confirmed by the Mini International Neuropsychiatric Interview (MINI).
- •Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≥24 for the current MDE at all Screening visits and Baseline (Day 1).
- •CGI-S score of ≥4 (moderately ill or worse) at the Screening visits and Baseline.
- •History of inadequate response to ≥1 but ≤4 prior ADT therapies (including the current ADT for the current MDE) ≥ 2 weeks at Screening and ≥ 8 weeks at Baseline.
- •Stable therapeutic dose of one of the following ADTs for the current MDE for ≥2 weeks prior to Screening and maintain the therapeutic dose throughout the study: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (IR or XR), desvenlafaxine, vilazodone, levomilnacipran, vortioxetine, bupropion or dextromethorphan//bupropion.
- •Detectable blood level of the approved ADT at Visits 1 and 2 of the Screening Period.
排除标准
- •MADRS Total Score improvement of ≥25% from the highest to the lowest score during the Screening Period and Baseline.
- •Clinically significant abnormal laboratory profiles, vital signs, or electrocardiograms (ECGs), per Investigator judgment.
- •Judged by the Investigator to be at significant risk for suicide or answers 'Yes' to items 4 or 5 on the Suicidal Ideation section of the C-SSRS in the 1 year before Screening; a history of suicide attempt in the last 2 years; or more than 2 lifetime suicide attempts.
- •History of psychotic disorder, including but not limited to schizophrenia, MDD with psychotic features, or bipolar I/II disorder with and without psychotic features.
- •Diagnosis within 12 months before Screening or current diagnosis of PTSD, OCD, panic disorder, intellectual disability, autism, acute stress disorder, or Cluster A or B personality disorder (per DSM-5 criteria).
- •History of substance use disorder within 6 months prior to Screening or currently using or had positive results (UDS) at Screening or Baseline for drugs of abuse.
- •History of alcohol and cannabis use disorder within 6 months prior to Screening and had a positive alcohol test at Baseline or a positive UDS for cannabis at Screening.
研究组 & 干预措施
NV-5138 400 mg oral capsules
Participants received either 800 or 1600 mg NV-5138 (2 or 4, 400 mg capsules) once daily for 4 weeks.
During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3. The dose at Week 4 was the same as stable dose at Week 3. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week.
干预措施: NV-5138 (Drug)
matched placebo
Participants received either 2 or 4 capsules of placebo once daily for 5 weeks.
干预措施: matched placebo (Drug)
结局指标
主要结局
Evaluation of the efficacy of NV-5138 as measured by the Montgomery-Asberg Depression Rating scale
时间窗: 5 weeks
Change from Baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. MADRS captures a clinician-rated score on a seven-point Likert scale for a score ranging from 0 to 60, with higher scores reflecting greater depression severity.
Change From Baseline to Week 4 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.
时间窗: Baseline to Week 4
MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes. A negative change from baseline indicates improvement in depressive symptoms.
次要结局
- Evaluation of the efficacy as measured by Clinical Global Impression-Severity (CGI-s) score(5 weeks)
- Change From Baseline to Each Scheduled Week in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.(Baseline to Weeks 1, 2 and 3)
- Change From Baseline to Each Scheduled Week in the Clinical Global Impression - Severity of Illness Score (CGI-S).(Baseline to Weeks 1, 2, 3 and 4)
- Change From Baseline to Each Scheduled Week in the The Hamilton Depression Rating Scale - 6 Items (HAM-D6) Total Score.(Baseline to Weeks 1, 2, 3 and 4)
- Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline to Weeks 1, 2, 3 and 4)