NCT00635700已完成2 期
Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 11
- 主要终点
- Conversion to Psychosis
研究概览
简要总结
This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for Psychosis
- •clinically referred
排除标准
- •prolonged corrected QT interval
- •history of syncope
研究组 & 干预措施
Ziprasidone
Experimental
Patients will be treated with Ziprasidone for 6 months
干预措施: ziprasidone (Drug)
Placebo
Placebo Comparator
Patients will be treated with placebo for 6 months
干预措施: placebo (Drug)
结局指标
主要结局
Conversion to Psychosis
时间窗: 6 months
Conversion to psychosis according to the Structured Interview for Psychosis-risk Syndromes (SIPS) require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria.
次要结局
- Change in Scale of Psychosis-risk Symptoms Total Score(baseline and 8 weeks)
研究者
研究点 (11)
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