NCT01469039已完成3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 623
- 试验地点
- 2
- 主要终点
- The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
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
- •Diagnosis of schizophrenia according to DSM-IV-TR criteria
- •Has been able to achieve outpatient status for more than 3 months in the past year
- •Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
- •Resides in a stable living situation
- •Willing and able to be confined to an inpatient study unit for 2 weeks or longer
排除标准
- •History of poor or inadequate clinical response to treatment with aripiprazole
- •History of treatment resistance
- •Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
- •Diagnosis of current substance dependence (including alcohol)
- •Pregnant, lactating, or breastfeeding
- •Receipt of any antipsychotic medication by IM injection within 60 days before Screening
- •Current involuntary hospitalization or incarceration
- •Hospitalized for more than 30 days during the 90 days before Screening
- •Additional inclusion/exclusion criteria may apply.
研究组 & 干预措施
ALKS 9072
Experimental
干预措施: ALKS 9072 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Data collected from baseline to day 85
The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.
次要结局
- Clinical Global Impression - Improvement (CGI-I) Scores at Day 85(85 Days)
研究者
研究点 (2)
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