NCT01234298撤回3 期
A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Shire
- 主要终点
- Negative Symptom Assessment (NSA-16) total score
研究概览
简要总结
To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has diagnosis of schizophrenia for at least 2 years
- •Subject has persistent predominant negative symptoms
- •Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
- •Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
- •Subject has been clinically stable and is in the non-acute phase of illness
排除标准
- •Subject has clinically notable positive symptoms
- •Subject is considered to be treatment refractory
- •Subject has current history of substance abuse/dependance
- •Subject is considered a suicide risk or risk to harm others
研究组 & 干预措施
SPD489 Low-Dose
Experimental
干预措施: SPD489 Low-Dose (Drug)
SPD489 High-Dose
Experimental
干预措施: SPD489 High-Dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Negative Symptom Assessment (NSA-16) total score
时间窗: up to 26 weeks
次要结局
- Positive and Negative Syndrome Scale (PANSS)(up to 26 weeks)
研究者
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