NCT07140913招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Bristol-Myers Squibb188 个研究点 分布在 9 个国家目标入组 424 人开始时间: 2025年10月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 424
- 试验地点
- 188
- 主要终点
- Change from baseline in Young Mania Rating Scale (YMRS) at Week 5
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.
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
- •Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.
- •Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).
- •The individual requires hospitalization for the acute exacerbation or relapse of mania.
- •Body mass index ≥ 18 and ≤ 40 kg/m
- •Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.
- •YMRS Total Score of ≥ 18 at Screening and at Baseline, and < 20% reduction in YMRS from screening to baseline.
排除标准
- •Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders.
- •Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test.
- •Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or "Yes" to any of the 5 items (C-SSRS behavior) with an event occurring within the 12 months before screening, or between screening and baseline.
- •History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.
- •History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
- •Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results.
- •Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT or AST and/or bilirubin > 1.5× ULN, unless in the context of Gilbert's syndrome.
- •All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]).
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Placebo + Lithium, Valproate, or Lamotrigine
Placebo Comparator
干预措施: Lithium (Drug)
Placebo + Lithium, Valproate, or Lamotrigine
Placebo Comparator
干预措施: Valproate (Drug)
Placebo + Lithium, Valproate, or Lamotrigine
Placebo Comparator
干预措施: Lamotrigine (Drug)
Placebo + Lithium, Valproate, or Lamotrigine
Placebo Comparator
干预措施: Placebo (Drug)
KarXT + Lithium, Valproate, or Lamotrigine
Experimental
干预措施: Xanomeline/Trospium Chloride (Drug)
KarXT + Lithium, Valproate, or Lamotrigine
Experimental
干预措施: Lithium (Drug)
KarXT + Lithium, Valproate, or Lamotrigine
Experimental
干预措施: Valproate (Drug)
KarXT + Lithium, Valproate, or Lamotrigine
Experimental
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Change from baseline in Young Mania Rating Scale (YMRS) at Week 5
时间窗: At Week 5
次要结局
- Change from baseline in Clinical Global Impressions Bipolar (CGI-BP) at Week 5(At Week 5)
- Occurrence of response at Week 5 assessed as the number of participants with a ≥ 50% decrease from baseline in Young Mania Rating Scale (YMRS) score(At Week 5)
- Occurrence of response at Week 5 assessed as the number of participants with a ≥ 1 change from baseline in CGI-BP(At Week 5)
- Number of participants with Treatment-emergent Adverse Events (TEAEs)(Up to Week 7)
- Number of participants with Serious Adverse Events (SAEs)(Up to Week 7)
- Number of participants with TEAEs leading to treatment discontinuation(Up to Week 5)
- Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to Week 7)
- Change from baseline in Barnes Akathisia Rating Scale (BARS) at Week 5(At Week 5)
- Change from baseline in Simpson Angus Scale (SAS) at Week 5(At Week 5)
- Change from baseline in Abnormal Involuntary Movement Scale (AIMS) at Week 5(At Week 5)
- Change from baseline in International Prostate Symptom Score (IPSS) at Week 5(At Week 5)
研究者
研究点 (188)
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