NCT06419582已完成2 期
A Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 29
- 主要终点
- Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21
研究概览
简要总结
The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be voluntarily hospitalized for a current manic episode.
- •Male and female participants 18 years to 75 years of age at the time of the screening visit.
- •Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m
- •Meets DSM-5 criteria for bipolar disorder type I, with or without mixed features, as confirmed by MINI interview with at least one well- defined prior mood episode (in addition to the current episode). The most recent prior manic episode must have occurred in the last 2 years.
- •Episode of mania must not exceed 12 weeks in duration.
- •Participants must be able and willing to discontinue all other psychotropic medications during the Screening Phase (e.g., antidepressant, antimanic, antipsychotic medications).
排除标准
- •Rapid cycling is excluded as defined herein by subjects who have experienced ≥ 6 distinct mood episodes in a year. Consecutive mood episodes must be demarcated either by a partial or full remission of at least 2 months' duration or by a switch to an episode of opposite polarity. Each manic or mixed episode must have lasted at least 1 week, and each hypomanic episode must have lasted at least 4 days.
- •Participants with a confirmed lifetime history of schizophrenia, psychotic disorders, dementia, delirium, amnesia, neurodegenerative disease, traumatic brain injury with clinically significant sequalae, seizure disorder, or other neurocognitive disorder. Previous diagnosis of psychotic spectrum disorders are allowable if the Investigator deems the diagnosis to be describing symptoms related to bipolar disorder.
- •Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
研究组 & 干预措施
BHV-7000
Experimental
干预措施: BHV-7000 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21
时间窗: Baseline (day 1) to day 21
The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.
次要结局
- Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score(Baseline (day 1) to day 21)
- Percentage of participants showing treatment response(Baseline (day 1) to day 21)
- Percentage of participants showing treatment remission(Baseline (day 1) to day 21)
- Change in Young Mania Rating Scale (YMRS) total score from baseline to day 7(Baseline (day 1) to day 7)
- Number of Participants With Clinically Significant Laboratory Abnormalities(Baseline (day 1) to day 21)
- Change in Young Mania Rating Scale (YMRS) total score from baseline to day 4(Baseline (day 1) to day 4)
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 21(Baseline (day 1) to day 21)
- Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication(Baseline (day 1) to day 21)
- Number of Participants With Vital Sign Abnormalities(Baseline (day 1) to day 21)
- Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation(Baseline (day 1) to day 21)
研究者
研究点 (29)
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