2025-521845-26-00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 Squibb Services Unlimited Company2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年1月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 5.
研究概览
简要总结
- To determine the superiority of KarXT plus lithium, valproate, or lamotrigine compared with placebo (pill with no medicine) plus lithium, valproate, or lamotrigine in reducing the severity of acute mania, with or without mixed features, in participants with BP-I.
- To determine if KarXT plus lithium, valproate or lamotrigine is better than placebo (“a dummy drug” with no medicine) plus lithium, valproate or lamotrigine in reducing the severity and symptoms of mania in participants with BP-I.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 to 65 years of age, inclusive, at the time of signing the ICF.
- •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 7.0.2 Standard with Borderline Personality Disorder version.
- •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/m2
- •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.
- •Clinical Global Impression Severity scale (CGI-BP) ≥ 4
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 Standard with Borderline Personality Disorder version at screening) including BP-I depression, BP-I with rapid cycling, first manic episode, BP-II, borderline personality disorder, and major depressive disorder.
- •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 Standard with Borderline Personality Disorder version 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 suicide attempt within 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 and 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]).
结局指标
主要结局
Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 5.
Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 5.
次要结局
- Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 5.
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (2)
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