NCT00265343已完成3 期
A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed the Protocol 25543 (NCT 00212836; P05817)
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
- 306
- 主要终点
- Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale
研究概览
简要总结
This is an extension study to further test
the efficacy and safety of asenapine compared with a
marketed agent (olanzapine) in the treatment of patients with
persistent negative symptoms of schizophrenia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Continue to meet all demographic and procedural
- •inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into
- •this extension trial.
- •Have demonstrated an acceptable
- •degree of compliance and completed the 25543
- •trial, and would benefit from continued treatment
- •according to the investigator.
排除标准
- •Have an uncontrolled, unstable clinically significant
- •medical condition.
- •Have been judged to be medically
- •noncompliant in the management of their disease.
研究组 & 干预措施
1
Experimental
asenapine
干预措施: asenapine (Drug)
2
Active Comparator
olanzapine
干预措施: olanzapine (Drug)
结局指标
主要结局
Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale
时间窗: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)
Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 \[best\]-96 \[worst\].
次要结局
- Change in Quality of Life Measured by Quality of Life Scale (QLS)(Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544))
研究者
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