NCT07172516招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 63
- 主要终点
- Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
研究概览
简要总结
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).
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 who experienced their first major depressive episode (MDE) prior to 50 years of age.
- •Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m
- •Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).
- •Current MDE must has a duration of ≥4 weeks and ≤12 months.
排除标准
- •Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
- •Participant has any nonbipolar psychiatric diagnosis.
- •Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
- •Participant has a symptomatic eating disorder within the 12 months prior to screening visit.
- •Participant has a Young Mania Rating Scale (YMRS) score >12 points at screening visit or randomization.
- •Participant has been hospitalized for mania within the 30 days prior to screening visit.
- •Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks).
- •Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months.
- •Participant has self-injurious behavior without intent to die in the 12 months prior to screening.
- •Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization.
- •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
Experimental
Azetukalner 20 mg
干预措施: Azetukalner (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
时间窗: Baseline to Week 6
次要结局
- Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score at Week 6.(Baseline to Week 6)
- Change from baseline in the MADRS total 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 Clinical Global Impression of Severity (CGI-S) score at Week 6.(Baseline to Week 6)
- Change from baseline in the MADRS total score at Week 1.(Baseline to Week 1)
- Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score at Week 6.(Baseline to Week 6)
研究者
研究点 (63)
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