2024-520165-32-00招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)
Bristol-Myers Squibb Services Unlimited Company14 个研究点 分布在 3 个国家目标入组 77 人开始时间: 2025年8月21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
- 77
- 试验地点
- 14
- 主要终点
- Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 3.
研究概览
简要总结
To determine if KarXT is better than placebo (“dummy drug” with no medicine) 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, v7.0.2).
- •Individual is experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
- •The individual requires hospitalization for the acute exacerbation or relapse of mania.
- •All psychotropic medications are washed out in no more than 14 days prior to the first dose of the study drug.
- •Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
- •Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.
排除标准
- •Any primary DSM-5-TR disorder, other than BP-I with mania or mania with mixed features within 12 months before screening (ie, primary focus of treatment, confirmed using MINI version 7.0.2 at screening), including BP-I with depression (for previous 3 months only), BP-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
- •Primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year)
- •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” on items 4 or 5 (C-SSRS – ideation) within 6 months of screening, or "Yes” to any of 5 items (C-SSRS – behavior) within 12 months of screening or between screening and baseline.
- •History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- •History or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
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 3.
Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 3.
次要结局
- Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 3.
- Occurrence of TEAEs, SAEs, and TEAEs leading to treatment discontinuation and change in C-SSRS responses during the treatment period.
- Change from baseline in BARS, SAS, AIMS, and IPSS (males aged ≥ 45 years only) at Week 3.
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (14)
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