A Multicenter, Open-Label Study to Evaluate Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-term Treatment of Bipolar Mania
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 118
- 主要终点
- The change in YMRS score from baseline at 6 months
研究概览
简要总结
The purpose of this study is to evaluate effect of risperidone as a long-term combination therapy to mood stabilizers in the treatment of bipolar mania
详细描述
The use of mood stabilizers such as lithium and carbamazepine is known to be effective for preventing and treating bipolar disorder. But the use of antipsychotic drugs is more effective in patients suffering severe episodes of mania as it elicits behavioral changes and spurs the effects of mood stabilizers. Antipsychotic drugs are used for patients who failed to respond to mood stabilizers or for the acute management of manic episodes associated with bipolar disorders.
This study aims to evaluate the safety and efficacy of risperidone as an adjunctive therapy to mood stabilizers in the long-term treatment (6months) of bipolar disorder using various assessment instruments, including the Young Mania Rating Scale. The Simpson-Angus Rating Scale will be also employed to assess the presence of extrapyramidal side effects and other adverse events. The patients will receive orally 0.5, 1, 2 mg risperidone tablet once daily for 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •In- or out-patient
- •Diagnosis of bipolar I disorder
- •most recent episode manic with or without psychotic features
- •YMRS > 20 (manic)
- •Need antipsychotic combination on the basis of clinicians' experience
排除标准
- •Rapid cycling
- •Risk of suicide or violence
- •History of Substance dependence within 3 months
- •Comorbidities
- •Unstable medical illness
- •Previous sensitivity history to risperidone
- •Pregnant woman or those without proper contraception
- •History of clozapine and one cycle of depot use prior to entry
- •History of treatment resistance: at least two mood stabilizers
- •Prior history of active treatment with risperidone
- •As for patients having wash-out period, patients that show 25% or more decrease in YMRS at baseline as compared to that at enrollment time, should be excluded.
结局指标
主要结局
The change in YMRS score from baseline at 6 months
次要结局
- The change from baseline in Clinical Global Impression-Severity (CGI-S) score at 6 months; The change from baseline in HAMD score at 6 months