An Open-Label Study Evaluating the Safety and Efficacy of Ropanicant in Participants With Moderate to Severe Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 19
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
This is an open-label, parallel-group study to evaluate the safety and efficacy of Ropanicant in participants with moderate to severe Major Depressive Disorder (MDD).
详细描述
Approximately 36 participants will be randomly assigned to receive Ropanicant either Ropanicant 45 mg once a day (QD), Ropanicant 30 mg twice a day (BID), or Ropanicant 45 mg BID for 2 weeks, in a ratio of 1:1:1 (12 participants in each treatment group). Following a screening period of up to 4 weeks, the participants will be treated for 2 weeks.
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
- None
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
- •Participants must meet the DSM-5 criteria for MDD without psychotic features and diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI).
- •Participants with a current major depressive episode of at least 4 weeks of duration prior to the screening visit.
- •Participants must have an MADRS score of ≥25 at the screening and the baseline visits.
- •Participants must have a score of ≥4 on Clinical Global Impression - Severity (CGI-S) Scale at the screening and the baseline visits.
排除标准
- •Participants who meet criteria for treatment-resistant depression during the current major depressive episode, which will be defined as being non-responders (less than 50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration as defined by the Massachusetts General Hospital (MGH) Antidepressant Treatment Response Questionnaire (ATRQ).
- •Participants taking antidepressant treatment (SSRIs and SNRIs) or any medication that is contraindicated with the use of monoamine oxidase inhibitors (eg, opioids, stimulants) within 2 weeks (or 5 half-lives, whichever is longer) prior to baseline and until the end of study visit.
- •Participants who do not agree to avoid tyramine rich diet from the start of dosing and until 2 weeks following last study drug administration.
- •Participants who are habitual smokers or using nicotine products.
研究组 & 干预措施
Ropanicant 45 mg BID
The participant will take 2 tablets/day (~12 hours apart for bid dosing).
干预措施: Ropanicant (Drug)
Ropanicant 45 mg QD
The participant will take 1 tablet/day in the morning (for qd dosing)
干预措施: Ropanicant (Drug)
Ropanicant 30 mg BID
The participant will take 2 tablets/day (~12 hours apart for bid dosing).
干预措施: Ropanicant (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: From Screening to Day 21
Frequency and severity of adverse events, treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
Number of Participants With Treatment-Emergent Adverse Events
时间窗: From Screening to Day 21
Participants with at least one Treatment-emergent adverse events (TEAEs) reported during the duration of the study.
次要结局
- Montgomery-Åsberg Depression Rating Scale (MADRS) score.(From Baseline to Day 14)
- Montgomery-Åsberg Depression Rating Scale (MADRS) Score(From Baseline to Day 14)