A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine Using Olanzapine as an Active Control in Subjects Diagnosed With Schizophrenia Who Completed Protocol P05688
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change in Weight From Baseline to Day 182
研究概览
简要总结
Participants who have completed the 6-week trial P05688 can be screened for eligibility for this 26-week extension study in which they will continue treatment. The purpose of this trial is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily (QD) is used as an active control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the short-term trial P05688, and judged by the investigator likely to benefit from continued treatment
排除标准
- •Occurrence(s) of an adverse event or other clinically significant finding(s) in the short-term trial P05688 that would prohibit the participant's continuation into the long-term extension
- •Clinical Global Impression-Severity of Illness (CGI-S) score of ≥6 (severely psychotic) at Baseline
- •Newly diagnosed or discovered psychiatric condition that would have excluded the participant from participation in the short-term trial P05688
研究组 & 干预措施
Asenapine 2.5 mg BID
干预措施: Asenapine (Drug)
Asenapine 2.5 mg BID
干预措施: Placebo Olanzapine (Drug)
Asenapine 5 mg BID
干预措施: Asenapine (Drug)
Asenapine 5 mg BID
干预措施: Placebo Olanzapine (Drug)
Olanzapine 15 mg QD
干预措施: Placebo Asenapine (Drug)
Olanzapine 15 mg QD
干预措施: Olanzapine (Drug)
Olanzapine 15 mg QD
干预措施: Placebo Olanzapine (Drug)
Placebo switched to Asenapine 2.5 mg BID
干预措施: Asenapine (Drug)
Placebo switched to Asenapine 2.5 mg BID
干预措施: Placebo Olanzapine (Drug)
结局指标
主要结局
Change in Weight From Baseline to Day 182
时间窗: Baseline (Day -1 of Short Term Trial) to Day 182 (Long-Term Extension)
次要结局
未报告次要终点