NCT00049946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
- 231
- 试验地点
- 32
- 主要终点
- Change from baseline in the PANSS total score.
研究概览
简要总结
A Placebo Controlled Study For 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
- 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
- •Patient must meet diagnostic criteria for schizophrenia.
排除标准
- •Patients with other psychotic disorders.
- •Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition.
- •Patients with a history of autistic disorder or another pervasive developmental disorder.
- •Patients with epilepsy or a history of seizures requiring treatment.
- •Patients who are excluded from taking the drug risperidone.
- •Patients who pose a current serious suicidal or homicidal risk.
- •Patients who are adequately stabilized on their treatment.
结局指标
主要结局
Change from baseline in the PANSS total score.
次要结局
- Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.
研究者
研究点 (32)
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