NCT00300963已完成2 期
A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy and Safety of a Fixed-Dose of Talnetant Versus Placebo Versus Risperidone in Subjects With Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 20
- 主要终点
- The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of talnetant vs. risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic schizophrenia patients.
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
- Double
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
- •Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
- •Require inpatient hospitalization.
- •Women may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method.
排除标准
- •Subject is in their first episode of schizophrenia.
- •Subject has other psychotic disorders or bipolar disorder.
- •Subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
- •Subject has a recent history of substance dependence, or tests positive for illicit drug.
- •Subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
- •Subject has any significant abnormalities in any of the screening tests (ECGs, labs, physical examinations, etc.).
- •Subject poses a current serious suicidal or homicidal risk.
- •Subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study.
- •Subject has recently or is currently participating in another clinical study.
- •Subject is stabilized on their current schizophrenia treatment.
- •Subject needs to take any of the medicines not permitted in the study, or has recently had ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation).
- •Subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years.
- •Subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.
结局指标
主要结局
The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
次要结局
- The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).
研究者
研究点 (20)
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