NCT00106405已完成2 期
A Pilot Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Forest Laboratories12 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2005年2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
- 35
- 试验地点
- 12
- 主要终点
- Young Mania Rating Scale (YMRS)
研究概览
简要总结
Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric emergencies and is associated with significant morbidity and mortality. The purpose of the study is to evaluate the safety and efficacy of open-label memantine in the acute management of adults with bipolar I disorder hospitalized for mania.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must have a documented clinical diagnosis of bipolar I disorder and must be currently experiencing a manic or mixed episode.
- •Patients must be voluntarily hospitalized with a primary diagnosis of mania.
排除标准
- •Rapid cycling bipolar disorder.
- •Suicidal risk.
- •First manic episode.
- •ECT, clozapine or a depot neuroleptic in the past 3 months.
- •Substance dependence.
- •Known HIV infection.
- •Co-morbid serious, uncontrolled systemic illness.
结局指标
主要结局
Young Mania Rating Scale (YMRS)
Mania Rating Scale
Clinical Global Impression
Montgomery Asberg Depression Rating Scale
Positive and Negative Syndrome Scale (PANSS)
PANSS - Excited Component
次要结局
未报告次要终点
研究者
研究点 (12)
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