ARIQUELI: Potentiation of Quetiapine Treatment in Bipolar 1 Nonresponders Patients With Lithium or Aripiprazole
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study
研究概览
简要总结
The purpose of this study is to determine whether Bipolar I Disorder refractory treatment with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and tolerability in maintenance treatment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
- •The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent
排除标准
- •Schizophrenia or schizoaffective disorder
- •Mental retardation
- •Unstable clinical diseases
研究组 & 干预措施
Lithium
Potentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L)
干预措施: Lithium (Drug)
Aripiprazole
Potentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg)
干预措施: Aripiprazole (Drug)
结局指标
主要结局
The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study
时间窗: 2 years
次要结局
未报告次要终点
研究者
Ricardo Alberto Moreno, M.D., Ph.D.
MD PhD
University of Sao Paulo