A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)
研究概览
简要总结
This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a BMI between 18.0 and 40.0 kg/m2, inclusive
- •Has a diagnosis of schizophrenia
- •Has a diagnosis of alcohol use disorder (AUD)
- •Has experienced an acute exacerbation of schizophrenia within the past 6 months
- •Additional criteria may apply
排除标准
- •Is pregnant or breastfeeding
- •Had first lifetime psychotic episode less than 1 year before screening or has experienced only a single lifetime psychotic episode
- •Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine
- •Has current or pending legal charges with the potential for incarceration
- •Has a positive drug screen for opiates
- •Additional criteria may apply
研究组 & 干预措施
Samidorphan + olanzapine (ALKS 3831)
Active study drug
干预措施: Samidorphan + olanzapine (ALKS 3831) (Drug)
Placebo + olanzapine
干预措施: Placebo + olanzapine (Drug)
结局指标
主要结局
Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)
时间窗: Up to 15 months
EEDS was defined as any of the following occurring during the double-blind period \& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC): 1. Hospitalization (includes psychiatric\& treatment of alcohol intoxication/withdrawal) 2. \>= 25% or \>= 15 point increase from randomization in PANSS total score 3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following: 3a. Score \>= 5 for subjects at a 2nd ad hoc visit with a score \<=3 at randomization 3b. Score \>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease
次要结局
- Number of Events of Exacerbation of Disease (EEDS)(Up to 15 months)
- Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27)(24 weeks)