2025-522775-29-00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)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 123
- 试验地点
- 19
- 主要终点
- Change from baseline in the MADRS total score at Week 6.
研究概览
简要总结
To assess the efficacy and safety of 20 mg azetukalner QD versus placebo for the treatment of bipolar depression.
研究设计
- 分配方式
- Randomized
- 主要目的
- Entire trial period
- 盲法
- Double (Analyst, Subject, Investigator, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 MDD, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
- •Participant is pregnant, breastfeeding, or planning to become pregnant.
- •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 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 prior to screening, presence of suicidal behavior.
- •Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week prior to randomization or within a period less than 5-times the drug's half-life prior to randomization, whichever is longer.
- •Participants with medical conditions that may interfere with the purpose or conduct of the study.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
XPF-010
Test
干预措施: XPF-010 (Drug)
结局指标
主要结局
Change from baseline in the MADRS total score at Week 6.
Change from baseline in the MADRS total score at Week 6.
次要结局
- Change from baseline in the CGI-S score at Week 6.
- Change from baseline in the MADRS total score at Week 1.
- Change from baseline in the SHAPS total score at Week 6.
研究者
Clinical Trial responsible person: Vice President Psychiatry Clinical Development
Scientific
Xenon Pharmaceuticals Inc.
研究点 (19)
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