NCT00097942已完成2 期
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment to Atypical Antipsychotics in Schizophrenia Patients With Persistent Residual Symptoms
Forest Laboratories26 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2004年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 26
- 主要终点
- Positive and Negative Symptom Scale (PANSS) - Total Score
研究概览
简要总结
Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving signal to noise ratio and thereby improving cognitive symptoms.
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
- •DSM-IV diagnosed Schizophrenia or schizoaffective disorder who are on a stable antipsychotic regimen with Brief Psychiatric Rating Scale (BPRS) total score greater than or equal to 26 and greater than or equal to 4 on at least one item
排除标准
- •Secondary diagnosis of Bipolar I disorder
- •Suicidal history
- •Organic brain disease
- •History of substance abuse
结局指标
主要结局
Positive and Negative Symptom Scale (PANSS) - Total Score
次要结局
- Clinical Global Impression - Severity (CGI-S)
- PANNS - Positive Score
- PANSS - Negative Score
- Calgary Depression Scale for Schizophrenia
- Brief Assessment of Cognition
- Clinical Global Impression - Improvement
研究者
研究点 (26)
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