A Proof-of-Concept, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 in Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 19
- 主要终点
- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
研究概览
简要总结
This is a multicenter, Phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of XEN1101 in subjects with Major Depressive Disorder.
详细描述
The study is divided into 3 stages: Screening - up to 4 weeks duration; Treatment - 6 weeks duration; Follow-up - 4 weeks duration. The total study duration per subject is estimated to be approximately 14 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
- Double (Participant, Investigator)
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
- •Be properly informed of the nature and risks of the study and given written informed consent.
- •Male or female, aged 18 through 65 years (inclusive) with a body mass index (BMI) ≤35 kg/m².
- •Subject must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current MDD and currently in a moderate to severe major depressive episode (MDE), confirmed using the Mini International Neuropsychiatric Interview (MINI).
- •Current MDE duration ≥2 months and <24 months at the time of screening.
- •Current illness severity that is at least moderate, defined as a score of ≥20 on the HAM-D17 at screening and on Day
- •Score ≥20 on the SHAPS at screening and on Day
- •Must be willing to comply with the study protocol for the full term of the study.
排除标准
- •A primary psychiatric diagnosis other than MDD as defined by DSM-5 (comorbid anxiety disorders [including agoraphobia, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), and panic disorder] are allowed).
- •Concomitant use of antidepressants and/or other disallowed pharmacotherapy (including benzodiazepines).
- •History of schizophrenia or other psychotic disorder, MDD with psychotic features, bipolar I or II disorder, or MDD with mixed features.
- •History of non-response to >1 antidepressant drug due to lack of efficacy in the current MDE.
- •Failing >3 antidepressant drug trials, for any reason, in the current MDE.
- •History of non-response to electroconvulsive therapy (ECT) in the past 10 years.
- •Active suicidal plan/intent in the past 6 months, or more than 1 lifetime suicide attempt.
- •Females who are pregnant, breastfeeding, or planning to become pregnant during the first administration of study drug until 3 months after the last dose of study drug.
- •Meets criteria for a substance use disorder within the past 12 months, with the exception of tobacco use, and/or has a positive urine toxicology screen for drugs of abuse.
- •Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
研究组 & 干预措施
XEN1101 10 mg
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day
干预措施: XEN1101 10 mg (Drug)
XEN1101 20 mg
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day
干预措施: XEN1101 20 mg (Drug)
placebo
During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
时间窗: From randomization to Week 10.
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.
时间窗: From baseline to end of treatment (Week 6).
次要结局
- Change in Snaith-Hamilton Pleasure Scale (SHAPS) score.(From baseline to end of treatment (Week 6).)
- Change in Beck Anxiety Inventory (BAI) score.(From baseline to end of treatment (Week 6).)