NCT00659919已完成4 期
Treatment of Neuroleptic Induced Acute Akathisia With Trazodone
BeerYaakov Mental Health Center1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2000年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Barnes Akathisia rating scale, Positive and Negative syndrome scale, Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms
研究概览
简要总结
Administration of trazodone for the treatment of neuroleptic induced acute akathisia in a cross-over fashion of 6 days duration. 3 days of placebo and 3 days of trazodone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with akathisia according to DSM-IV criteria at least mild akathisia.
排除标准
- •Change of pharmacologic regimen 7 days prior to study entry
- •Significant systemic disease
- •The presence of chronic akathisia
- •Patients unable to cooperate
研究组 & 干预措施
Placebo
Placebo Comparator
The patients in this arm received placebo
干预措施: Placebo (Drug)
Trazodone
Active Comparator
The patients on this arm received Trazodone for 3 consecutive days
干预措施: Trazodone (Drug)
结局指标
主要结局
Barnes Akathisia rating scale, Positive and Negative syndrome scale, Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms
次要结局
未报告次要终点
研究者
研究点 (1)
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