A Multicenter, Double-Blind, Randomized Withdrawal Study in Patients With Schizophrenia Receiving Either Iloperidone Long-Acting Injection (LAI) or Placebo Injection
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 23
- 主要终点
- Time to exacerbation of symptoms
研究概览
简要总结
The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 18 to 65 years of age (inclusive)
- •Diagnosed with schizophrenia per DSM-5 criteria
- •In need of ongoing psychiatric treatment
排除标准
- •DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months
研究组 & 干预措施
iloperidone
During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (iloperidone long-acting injection) as long-acting intramuscular injections for up to 52 weeks.
干预措施: iloperidone (Drug)
placebo
During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (matching placebo) as long-acting intramuscular injections for up to 52 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Time to exacerbation of symptoms
时间窗: Up to 52 weeks post-randomization
As measured by the time to first exacerbation of psychiatric symptoms
次要结局
未报告次要终点