Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Quetiapine-Referenced, Fixed-Dose Study of Lu AA39959 in the Treatment of Depression in Patients With Bipolar I or II Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Depressive symptoms as measured by the change from baseline in total MADRS score
研究概览
简要总结
This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.
详细描述
Bipolar disorder is a common lifelong psychiatric disorder characterized by recurrent mood swings with manic or hypomanic episodes alternated with depressive episodes of longer duration. Patients spend more time in depression than in (hypo)mania over their life time. The main goals for the treatment of bipolar disorder are resolution of symptoms, return to premorbid level of social functioning and prevention of future episodes.
Although there are many treatments for bipolar disorder, few are approved, and they have limitations in their use due to safety and tolerability issues. Recommendations exist to use mood stabilisers, antipsychotics or a combination thereof with or without antidepressants and the polypharmacy employed in many cases is a reason for concern. There is a major medical need for more effective treatments in monotherapy with a reduced potential for adverse effects. This study evaluates the efficacy and safety of the new drug, Lu AA39959, in treatment of depression in patients with bipolar disorder.
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 (Participant, Investigator)
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
- •Current major depressive episode of bipolar II or I disorder, according to DSM-IV TR
- •Moderate to severe depression
- •History of at least one documented mania or hypomania episode
- •Absence of current mania or hypomania
排除标准
- •Any current psychiatric disorder other than bipolar disorder defined in the DSM-IV TR
- •Any substance disorder with the previous 6 months
- •Use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study
- •ECT within 6 months before the study
- •Female of childbearing potential and not using adequate contraception
- •Other protocol-defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Lu AA39959
干预措施: Lu AA39959 (Drug)
Placebo
干预措施: Placebo (Drug)
Quetiapine
干预措施: Quetiapine (Drug)
结局指标
主要结局
Depressive symptoms as measured by the change from baseline in total MADRS score
时间窗: 8 weeks
次要结局
- Global impression (Clinical Global Impression; CGI-BP-Severity/Improvement), depression/anxiety symptoms (Hamilton Depression/Anxiety scale; HAM-D/A), mania symptoms (Young Mania Rating Scale; YMRS), adverse events(8 weeks)