A Phase 2, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of Samidorphan, a Component of ALKS 3831, in Adults With Schizophrenia Treated With Olanzapine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 1
- 主要终点
- Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score
研究概览
简要总结
This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 50 years, inclusive
- •Body mass index (BMI) of 17-30 kg/m2, inclusive
- •Diagnosis of schizophrenia that is clinically stable
排除标准
- •Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting <2 years
- •Current diagnosis of alcohol or drug use disorder, moderate or severe
- •Clinically significant or unstable medical illness, condition, or disorder
- •Pregnant or breastfeeding
- •Significant changes in diet or exercise regimen or plans to join a weight management program during the study
- •Opioid medications taken within 14 days and/or need to take opioid medication during the study period
- •History of hypersensitivity to or intolerance of olanzapine
- •Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year
研究组 & 干预措施
Low Dose
Olanzapine + low dose samidorphan tablets taken once daily
干预措施: Samidorphan (Low Dose) (Drug)
Low Dose
Olanzapine + low dose samidorphan tablets taken once daily
干预措施: Olanzapine (Drug)
Medium Dose
Olanzapine + medium dose samidorphan tablets taken once daily
干预措施: Samidorphan (Medium Dose) (Drug)
Medium Dose
Olanzapine + medium dose samidorphan tablets taken once daily
干预措施: Olanzapine (Drug)
High Dose
Olanzapine + high dose samidorphan tablets taken once daily
干预措施: Samidorphan (High Dose) (Drug)
High Dose
Olanzapine + high dose samidorphan tablets taken once daily
干预措施: Olanzapine (Drug)
Placebo
Olanzapine + placebo tablets taken once daily
干预措施: Placebo (Drug)
Placebo
Olanzapine + placebo tablets taken once daily
干预措施: Olanzapine (Drug)
结局指标
主要结局
Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score
时间窗: Baseline (Day 8) to Day 92 (end of study Part A)
Change from baseline (Day 8) to Day 92 (end of study Part A). The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.
次要结局
- Percentage of Subjects Exhibiting Significant Weight Gain at Day 92(Baseline (Day 8) to Day 92 (end of study Part A))
- Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92(Baseline (Day 8) to Day 92 (end of study Part A))
- Percent Change in Body Weight (Kilogram) From Baseline to Day 92(Baseline (Day 8) to Day 92 (end of study Part A))
- Absolute Change in Body Weight (kg) From Baseline to Day 92(Baseline (Day 8) to Day 92 (end of study Part A))