A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
研究概览
简要总结
This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2
- •Meets criteria for the diagnosis of schizophrenia
- •Resides in a stable living situation when not hospitalized
- •Is willing and able to provide government-issued identification
- •Additional criteria may apply
排除标准
- •Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
- •Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
- •Subject poses a current suicide risk
- •Subject has a history of treatment resistance
- •Subject has a history of poor or inadequate response to treatment with olanzapine
- •Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening
- •Subject has a diagnosis of moderate or severe alcohol or drug use disorder
- •Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
- •Additional criteria may apply
研究组 & 干预措施
ALKS 3831
Administered as a coated bilayer tablet
干预措施: ALK3831 (Drug)
Olanzapine
Administered as a coated bilayer tablet
干预措施: Olanzapine (Drug)
Placebo
Administered as a coated bilayer tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
时间窗: 4 weeks
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.
次要结局
- Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4(4 weeks)
- Incidence of Adverse Events(Approximately 4 weeks)