jRCT2041250170招募中不适用
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 TakingLithium, Valproate, or Lamotrigine
未提供0 个研究点目标入组 27 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 65age old under（—）
- 性别
- All
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
- •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.
- •Bodymass index >= 18 and =< 40 kg/m2
- •Currently experiencing an acute episode of mania or mania with mixed featureswitha 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 PersonalityDisorderversion
- •at screening) including BP-Idepression, BP-Iwith 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 atscreening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6months before screeningor between screening and baseline, or suicide attempt within 12 months beforescreening, 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 x ULN
- •for ALT and AST and/or bilirubin > 1.5x 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]).
研究者
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