A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 81
- 主要终点
- Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6
研究概览
简要总结
X-NOVA3 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age
- •Body Mass Index (BMI) ≤40 kg/m2
- •Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI)
- •Participant's current MDE has a duration of ≥6 weeks and ≤24 months.
排除标准
- •Participant has a primary diagnosis of a mood disorder other than MDD.
- •Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder.
- •Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post traumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and/or agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator.
- •Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening.
- •Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or >1 suicide attempt > 24 years of age.
- •Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening.
- •Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization.
- •Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ).
- •Participants with medical conditions that may interfere with the purpose or conduct of the study
- •Participant is pregnant, breastfeeding, or planning to become pregnant.
研究组 & 干预措施
Azetukalner
Azetukalner 20 mg
干预措施: Azetukalner (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6
时间窗: Baseline to Week 6
The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.
Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6
时间窗: Baseline to Week 6
The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.
次要结局
- Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) score at Week 6(Baseline to Week 6)
- Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 1(Baseline to Week 1)
- Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6(Baseline to Week 6)
- Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) score at Week 6(Baseline to Week 6)
- Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 1(Baseline to Week 1)
- Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6(Baseline to Week 6)
- To assess the safety and tolerability of azetukalner (e.g., adverse events)(From screening (approximately 4 weeks prior to baseline) through to 8 weeks post-final dose.)