A Multi-center, Randomized, Double-blind, Parallel Group, Placebo-controlled 52 Weeks Clinical Trial to Evaluate Efficacy and Safety of Oxcarbazepine p.o.(300-1200 mg/Day) as Adjuvant Therapy in the Bipolar Disorder I or II Treatment

Novartis0 个研究点目标入组 55 人开始时间: 2003年1月1日最近更新: 2023年12月14日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis
入组人数: 55
主要终点: Duration of remission

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with bipolar disorder type I or II.

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: Double

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•History of bipolar disorder type I or II

排除标准

•Other serious medical conditions
•Treatment with antiepileptic medications
•Other protocol-defined inclusion/exclusion criteria may apply.

结局指标

主要结局

Duration of remission

次要结局

Time to new maniac/hypomanic episode
Time to new depressive episode
Change from baseline in functional activity
Daily mood fluctuation
Number of relapsed patients at study completion and type/severity of episode

研究者

发起方

Novartis

申办方类型

Industry

责任方

Sponsor

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