NCT01043679Unknown4 期
A Randomized Open-label Active-controlled Study to Evaluate the Efficacy and Safety of Utapine Versus Seroquel in Patients With Bipolar Mania
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients.
详细描述
Utapine and Serquel belong to anti-bipolar medication family, both are approved by DOH (Department of Health, Taiwan), both has same ingredient but different manufacture. From clinical trial reports, both has excellent effectiveness and safety. The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients for different ingredient and different manufacture.
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
- Single (Participant)
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
- 是
入选标准
- •Male or female age 18-65 years with diagnosis of bipolar I disorder who will be included by DSM-IV criteria made at least one manic or mixepisode record before study entry.
- •Having a minimum score of 20 on the Young Mania Rating Scale (YMRS), plus a score of at least 4 on two of the core YMRS items of Irritability,Speech, Content, and Disruptive/Aggressive Behavior.
- •At least 4 will be on the Severity of Illness item of the Clinical Global ImpressionsNBipolar(CGINBP)assessment tool.
- •Patient with good compliance to study medicine and adherence to study protocol.
排除标准
- •Had received treatment with clozapine within 28 days of the start of the trial.
- •Had been hospitalised for 3 weeks or longer for the index manic episode.
- •DSM-IV criteria for rapid cycling or a current mixed episode.
- •Intolerance or lack of response to quetiapine or clozapine before this trial be diagnosed by investigator.
- •Neurodegenerative disease eg:Parkinson desease、Huntington disease、Pick's disease.
- •Medicine or drugs which can change mental condition be judged by investigator.
- •EKG abnormality
- •Drug or alcohol abuser
研究组 & 干预措施
Seroquel
Active Comparator
Efficacy and Safety of Seroquel
干预措施: Seroquel (Drug)
Utapine
Active Comparator
Efficacy and Safety of Utapine
干预措施: Utapine (Drug)
研究者
研究点 (1)
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