EUCTR2014-001211-39-PL进行中（未招募）1 期
A Phase 2, Efficacy, Safety, and Tolerability Study ofALKS 3831 in Schizophrenia with Alcohol Use Disorder - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Has a BMI between 18.0 and 40.0 kg/m2, inclusive.
- •2. Has a diagnosis of schizophrenia.
- •3. Has a diagnosis of alcohol use disorder (AUD).
- •4. Has experienced an acute exacerbation of schizophrenia within the past 6 months.
- •5. Additional criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Is pregnant or breastfeeding.
- •2. Had first lifetime psychotic epizode less than 1 year before screening or has experienced only a single lifetime psychotic episode.
- •3. Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine.
- •4. Has current or pending legal charges within the potential for incarceration.
- •5. Has a positive drug screen for opiates.
- •6. Additional criteria may apply.
研究者
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