Efficacy and Tolerability of the Combination of LIthium and CArbamazepine Compared to Lithium and VALproic Acid in the Treatment of Young Bipolar Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 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 the efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients.
详细描述
After the diagnostic assessments, the patients are allocated for one of the following groups of treatment:
Group I: lithium + valproic acid
Group II: lithium + carbamazepine
Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Scales raters will be blind to the treatment.
During phase II and III will continue only patients that achieve response, measured according to initial symptoms score in phase I.
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 35 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 plus carbamazepine
combination of the two drugs in standard dosage
干预措施: lithium plus carbamazepine (Drug)
lithium plus valproate
combination of the two drugs in standard dosage
干预措施: lithium plus valproate (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: August 2012
次要结局
- Secondary outcome will include the proportion of patients that had response but not remission to each treatment at the end of each phase of the study(August 2012)
研究者
Ricardo Alberto Moreno, M.D., Ph.D.
MD PhD
University of Sao Paulo