2025-523202-32-00招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 22
- 主要终点
- Change from baseline in the HAMD-17 score at Week 6.
研究概览
简要总结
To assess the efficacy of 20 mg azetukalner once daily for the treatment of Major Depressive Disorder.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 is pregnant, breastfeeding, or planning to become pregnant
- •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 onset; Posttraumatic 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.
研究组 & 干预措施
XPF-010
Test
干预措施: XPF-010 (Drug)
Placebo to match XPF-010
Placebo
干预措施: Placebo to match XPF-010 (Drug)
结局指标
主要结局
Change from baseline in the HAMD-17 score at Week 6.
Change from baseline in the HAMD-17 score at Week 6.
次要结局
- Change from baseline in the HAMD-17 score at Week 1
- Change from baseline in the CGI-S score at Week 6
- Change from baseline in the SHAPS score at Week 6
研究者
Medical Affairs
Scientific
Xenon Pharmaceuticals Inc.
研究点 (22)
Loading locations...
相似试验
招募中
2 期
A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive DisorderMajor Depressive DisorderNCT07276997AbbVie195
招募中
2 期
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant ResponseNCT07284667ACADIA Pharmaceuticals Inc.153
招募中
2 期
A Study to Evaluate the Effectiveness of DT-101 in Patients With DepressionNCT07300969Draig Therapeutics Ltd300
招募中
3 期
Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive DisorderMajor Depressive Disorder2024-520333-68-00Vanda Pharmaceuticals Netherlands B.V.300
招募中
2 期
A Phase IIb Two-Cohort, Randomised, Placebo controlled, Double blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients with Chronic Heart FailureChronic Heart Failure2023-510148-19-00AstraZeneca AB235